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EC number: 904-797-4 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Auto flammability
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- Storage stability and reactivity towards container material
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
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- Toxicological Summary
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- Genetic toxicity
- Carcinogenicity
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- Specific investigations
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- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratory, Portage, MI
- Age at study initiation: Approximately 8 weeks (young adults)
- Weight at study initiation: 230-264 grams (males) and 166-200 grams (females)
- Fasting period before study: fasted overnight prior to test material administration
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum, except for overnight fasting prior to dosing. Purina Laboratory Rodent Chow (Registered Trademark of the Ralston-Purina Company, St. Louis, Missouri) was used.
- Water (e.g. ad libitum): ad libitum, except for overnight fasting prior to dosing. Water was furnished by the City of St. Louis, Missouri.
- Acclimation period: at least five days - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): The test material was administered as a 372 mg/mL suspension in corn oil. The volume administered was adjusted according to body weight and the dosage to be given. - Doses:
- 1984, 2500, 3150, 3969 and 5000 mg/kg
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for death and overt signs of toxicity were made three times within the first eight hours after dosing and twice daily (morning and afternoon) thereafter. Body weights were recorded on days 0 (day of dosing), 7, and 14.
- Necropsy of survivors performed: yes (After 15 days on test, the surviving animals were sacrificed. Necropsies were performed on all animals.) - Statistics:
- The acute oral LD50 for each sex and for the combined sexes was calculated using the method of Finney [Finney, D.J., (1971). Probit Analysis (3rd edition). Cambridge University Press].
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 604 mg/kg bw
- 95% CL:
- >= 2 247 - <= 2 940
- Remarks on result:
- other: Slope: 9.3
- Remarks:
- 95 % Confidence Limits: 4.7 and 13.8
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 925 mg/kg bw
- 95% CL:
- >= 2 414 - <= 3 518
- Remarks on result:
- other: Slope 11.2
- Remarks:
- 95 % Confidence Limits: 3.9 and 18.5
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 304 mg/kg bw
- 95% CL:
- >= 1 421 - <= 2 790
- Remarks on result:
- other: Slope. 9.4
- Remarks:
- 95 % Confidence Limits: 1.8 and 17.0
- Clinical signs:
- Toxicity to the nervous system was suggested by several of the clinical abnormalities that were observed during the early part of this study. Sedation, ptosis, and ataxia were each observed in at least 12 animals by the first day after dosing and each occurred in a dosage-related manner. Prostration and lacrimation also occurred, but these abnormalities were observed in fewer animals. Gastrointestinal involvement was indicated by diarrhea, but this may have been induced by the corn oil used as the dosing vehicle.
- Gross pathology:
- Necropsy findings of gastrointestinal (GI) distension, discoloration of the intestines, and apparent gastrointestinal hemorrhage indicated that the GI tract was affected by this test material.
- Interpretation of results:
- not classified
- Conclusions:
- The acute oral LD50 was calculated to be 2604 mg/kg bw with 95% CL of 2247 -2940 mg/kg.
For male rats, the acute oral LD50 was calculated to be 2925 mg/kg.
For female rates, it was calculated to be 2304 mg/kg bw. - Executive summary:
When the test item (Toluene soluble terphenyl and quarterphenyls) was administered to fasted albino rats of both sexes, the acute oral LD50 was calculated to be 2604 mg/kg bw with 95% CL of 2247 -2940 mg/kg. For male rats, the acute oral LD50 was calculated to be 2925 mg/kg, and for female rates, it was calculated to be 2304 mg/kg bw. Observations considered to be treatment related included sedation, ptosis, ataxia, prostration, lacrimation, and diarrhoea. Necropsy findings indicated that the gastrointestinal tract was affected.
Acute Oral Toxicity to Rats Mean Body Weight and Mortality Summary
Dosage (mg/kg) |
Mean body weight (Grams) |
N° deaths / N° dosed |
Days of death postdosing |
||
Day 0 |
Day 7 |
Day 14 |
|||
Male rats |
|||||
1984 |
247 |
301 |
352 |
0/5 |
- |
2500 |
248 |
282 |
334 |
2/5 |
2,2 |
3150 |
251 |
278 |
326 |
2/5 |
1,2 |
3969 |
248 |
- |
- |
5/5 |
1,1,2,2,3 |
5000 |
238 |
- |
- |
5/5 |
1,2,2,2,2 |
Female rats |
|||||
1984 |
181 |
210 |
235 |
1/5 |
1 |
2500 |
186 |
221 |
247 |
4/5 |
1,2,2,2 |
3150 |
179 |
209 |
228 |
4/5 |
1,2,2,2 |
3969 |
179 |
- |
- |
5/5 |
1,1,2,2,2 |
5000 |
174 |
- |
- |
5/5 |
1,1,1,2,2 |
Table 2 | ||||
Acute Oral Toxicity to Rats Summary of Observations During Life | ||||
Observation Dosage (mg/kg) | No. Observed/No. Dosed* | |||
Male | Female | Combined | Comments | |
Sedation | ||||
1984 | 1/5 | 0/5 | 1/10 | Day 0 only |
2500 | 3/5 | 3/5 | 6/10 | Days 1, 2, and 5 |
3150 | 2/5 | 3/5 | 5/10 | Days 1, 2, and 5 |
3969 | 5/5 | 5/5 | 10/10 | Days 0 thourgh 2 |
5000 | 4/5 | 5/5 | 9/10 | Day 1 only |
Ataxia | ||||
2500 | 2/5 | 0/5 | 2/10 | Days 1 and 2 |
3150 | 1/5 | 1/5 | 2/10 | Days 1 and 2 |
3969 | 1/5 | 4/5 | O/J.0 | Days 1 and 2 |
5000 | 1/5 | 3/5 | 4/10 | Day 1 only |
Prostration | ||||
3150 | 0/5 | 2/5 | 2/10 | Day 1 only |
3969 | 2/5 | 1/5 | 3/10 | Day 1 only |
5000 | 0/5 | 1/5 | 1/10 | Day 1 only |
Ptosis | ||||
2500 | 2/5 | 0/5 | 2/10 | Days 1 and 2 |
3150 | 2/5 | 3/5 | 5/10 | Days 1 and 2 |
3969 | 4/5 | 5/5 | 9/10 | Days 0 through 2 |
5000 | 4/5 | 4/5 | 8/10 | Day 1 only |
Lacrimation | ||||
2500 | 0/5 | 1/5 | 1/10 | Day 1 only |
3150 | 0/5 | 3/5 | 3/10 | Day 1 only |
3969 | 2/5 | 0/5 | 2/10 | Day 1 only |
Diarrhea | ||||
1984 | 0/5 | 1/5 | 1/10 | Day 1 only |
2500 | 4/5 | 1/5 | 5/10 | Days 1 and 2 |
3150 | 4/5 | 3/5 | 7/10 | Days 1 and 2 |
3969 | 5/5 | 5/5 | 10/10 | Day 1 only |
5000 | 5/5 | 3/5 | 8/10 | Day 1 only |
Lack of Feces | ||||
3150 | 2/5 | 1/5 | 3/10 | Days 1 and 2 |
3969 | 1/5 | 0/5 | 1/10 | Day 2 only |
Chromodacryorrhea | ||||
2500 | 2/5 | 0/5 | 2/10 | Days 1 and 2 |
3969 | 1/5 | 0/5 | 1/10 | Day 2 only |
5000 | 2/5 | 0/5 | 2/10 | Day 1 only |
Porphyrin Around the Nose | ||||
2500 | 1/5 | 1/5 | 2/10 | Days 1 and 2 |
3150 | 2/5 | 0/5 | 2/10 | Day 2 only |
3969 | 2/5 | 2/5 | 4/10 | Days 1 and 2 |
5000 | 1/5 | 1/5 | 2/10 | Day 1 only |
Piloerection | ||||
3969 | 0/5 | 1/5 | 1/10 | Day 1 only |
Dark (Purple) Coloration of the Tail | ||||
2500 | 1/5 | 0/5 | 1/10 | Day 1 only |
Incomplete Administration ("Bakflush) of Test Material | ||||
3969 | Ö/5 | i/s | 1/10 | Day 0 only |
*For the number of -living animals during the observation periods listed above, refer to Table 1. | ||||
Table 3 | |||
Acute Oral Toxicity to Rats Summary of Necropsy Observations | |||
Observation Dosaqe (mg/kg) | No. Observed/No. Dosed | ||
Male | Female | Combined | |
Gastrointestinal Distension | |||
1984 | 0/5 | 1/5 | 1/10 |
2500 | 1/5 | 2/5 | 3/10 |
3150 | 1/5 | 1/5 | 2/10 |
3969 | 3/5 | 1/5 | 4/10 |
5000 | 3/5 | 3/5 | 6/10 |
Dark and/or Red Discoloration of the Intestinal Tract | |||
1984 | 0/5 | 1/5 | 1/10 |
2500 | 1/5 | 1/5 | 2/10 |
3150 | 1/5 | 2/5 | 3/10 |
3969 | 4/5 | 3/5 | 7/10 |
5000 | 3/5 | 4/5 | 7/10 |
Apparent Gastrointestinal Hemorrhage | |||
5000 | 0/5 | 2/5 | 2/10 |
Urine Stained Fur | |||
1984 | 0/5 | 1/5 | 1/10 |
2500 | 2/5 | 2/5 | 4/10 |
3150 | 2/5 | 2/5 | 4/10 |
3969 | 3/5 | 3/5 | 6/10 |
5000 | 4/5 | 5/5 | 9/10 |
Diarrheal Feces or Feces Stained Fur | |||
1984 | 0/5 | 1/5 | 1/10 |
2500 | 2/5 | 1/5 | 3/10 |
3150 | 2/5 | 1/5 | 3/10 |
3969 | 4/5 | 3/5 | 7/10 |
5000 | 5/5 | 1/5 | 6/10 |
Lacrimation | |||
1984 | 0/5 | 1/5 | 1/10 |
Excessive Salivation | |||
3969 | 0/5 | 1/5 | 1/10 |
5000 | 0/5 | 1/5 | 1/10 |
Red Discharge from the Nose and/or the Eyes | |||
1984 | 0/5 | 1/5 | 1/10 |
2500 | 1/5 | 2/5 | 3/10 |
3150 | 1/5 | 1/5 | 2/10 |
3969 | 2/5 | 3/5 | 5/10 |
5000 | 3/5 | 3/5 | 6/10 |
Red Material on the Forelegs (Apparently Rubbed off the Face) | |||
2500 | 0/5 | 1/5 | 1/10 |
Pale Coloration of the Liver | |||
1984 | 0/5 | 1/5 | 1/10 |
Autolysis of Internal Tissues | |||
2500 | 1/5 | 2/5 | 3/10 |
3150 | 1/5 | 3/5 | 4/10 |
3969 | 1/5 | 3/5 | 4/10 |
5000 | 2/5 | 1/5 | 3/10 |
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Isaac's Farm, Litchfield, Illinois
- Age at study initiation: approximately 10 weeks (young adults)
- Weight at study initiation: 2.42 - 2.80 kilograms
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum. Purina Rabbit Chow (Registered Trademark of the Ralston-Purina Company, St. Louis, Missouri) will be used.
- Water (e.g. ad libitum): ad libitum. Water will be furnished by the City of St. Louis, Missouri.
- Acclimation period: at least five days - Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the dorsal surface
- % coverage: 10-30% of total body surface
- Type of wrap if used: The test material was held in place by means of an occlusive wrap of latex rubber secured by bandaging and elastic tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The excess material was wiped from the animal.
- Time after start of exposure: The occlusive wrap was removed after approximately 24 hours - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5 animals per dose per sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for death and overt signs of toxicity were made three times during the first eight hours following test material administration and twice daily (morning and afternoon) thereafter. Body weights were recorded on days 0 (day of dosing), 7, and 14.
- Necropsy of survivors performed: yes (after 15 days on test, all animals were sacrificed and necropsies were perfromed on all animals) - Statistics:
- The acute dermal LD50 for each sex and for the combined sexes was calculated using the method of Finney [Finney, D.J., (1971). Probit Analysis (3rd edition). Cambridge University Press].
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No deaths were observed in animals of either sex.
- Clinical signs:
- All clinical abnormalities observed during this study were considered to result from direct contact between the test material and the skin in the exposed area. Erythema of the skin occurred in nine animals. The duration of this effect ranged from two to thirteen days in individual, affected animals. Edema of the skin was observed in one female and two male animals on the first day after test material administration. Areas of inhibited growth of fur occurred in one female and two male animals and were observed on the last three days of the study.
- Gross pathology:
- At necropsy, most of the findings reflected the effect of direct contact of the skin in the exposed area with the test material. Redness of the skin was observed in two male and three female animals. Areas of inhibited fur growth occurred in one male and two female rabbits. Hardened skin was observed in one male animal. Raised skin occurred in one female animal. One animal of each sex had defatted skin. Both kidneys of one male animal had pitted exteriors, but this was not considered to represent toxicity of the test material.
- Interpretation of results:
- not classified
- Conclusions:
- The acute dermal LD50 for MCS-1980 was determined to be above 5000 mg/kg bw.
- Executive summary:
No deaths followed a dermal application of 5000 mg/kg bw of Toluene soluble terphenyl and quarterphenyls to the shaved and abraded dorsal surface of albino of both sexes. Therefore, the acute dermal LD50 of this material is considered to be in excess of 5000 mg/kg bw. Clinical abnormalities included erythema, edema, and inhibited growth of fur in the exposed area.
Acute Dermal Toxicity to Rabbits Mean Body Weight and Mortality Summary
Dosage (mg/kg) |
Mean body weight (Kg) |
N° deaths / N° dosed |
Days of death postdosing |
||
Day 0 |
Day 7 |
Day 14 |
|||
Male rats |
|||||
5000 |
2.58 |
2.78 |
3.00 |
0/5 |
- |
Female rats |
|||||
5000 |
2.62 |
2.78 |
3.03 |
0/5 |
- |
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Draize, J. H., Woodard, G., and Calvery, H. 0. (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J. Pharmacol. Exp. Thera p. 82: 377-390.
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Isaac's Farm, Litchfield, Illinois
- Age at study initiation: Approximately 10 weeks (young adults)
- Weight at study initiation: 2.16-2.60 kilograms
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum (Purina Rabbit Chow® (Registered Trademark of the Ralston-Purina Company, St, Louis, Missouri))
- Water (e.g. ad libitum): ad libitum (water furnished by the City of St. Louis, Missouri)
- Acclimation period: at least five days - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A mass of 0.5 ± 0.009 grams of the test material - Duration of treatment / exposure:
- single exposure, 24 h exposure
- Observation period:
- The initial (day one) observation for skin irritation was made approximately one hour after the removal of the wrappings. Results were recorded at 24 and 72 hours after topical application. The animal that had irritation present during the 72 hour examination was also observed for signs of irritation on the seventh and tenth days after exposure.
- Number of animals:
- 3 animals per sex
- Details on study design:
- TEST SITE
- Area of exposure: dorsal surface
- % coverage: The test material was applied to the skin under one inch square gauze patches
- Type of wrap if used: wrap of latex rubber secured by bandaging and elastic tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the excess material was wiped from the treated sites of the animals
- Time after start of exposure: aproximately 24 hours
SCORING SYSTEM: Dermal irritation was scored by the method of Draize (1944) - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 8
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Intact and abraded skin
- Remarks:
- 48 h value was not evaluted.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Intact skin
- Remarks:
- 48 h value was not evaluted.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.13
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Abraded skin
- Remarks:
- 48 h value was not evaluted.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks:
- .
- Remarks on result:
- other: Intact and abraded skin
- Remarks:
- 48 h value was not evaluted.
- Irritant / corrosive response data:
- All skin irritation had subsided by the tenth day after test material administration. Defatting of the skin on all four exposed sites occurred in one animal on the tenth day after exposure. No signs of systemic toxicity were observed.
- Interpretation of results:
- not irritating
- Conclusions:
- The key study for skin irritation/corrosion is a K1 GLP study performed similar to OECD guideline 404, in which the Draize scoring system is used. New Zealand White rabbits were exposed to 0.5 g of the test material for 24 hours under occlusive coverage upon both intact and abraded shaved skin. Subsequently, the excess material was wiped from the treated sites of the animals. Scorings were recorded 24 and 72 hours after topical application. Animals showing signs of irritation after 72 hours were further observed for signs of irritation on the seventh and tenth day after exposure. Only signs of slight erythema were observed.
- Executive summary:
The key study for skin irritation/corrosion is a K1 GLP study performed similar to OECD guideline 404, in which the Draize scoring system is used. New Zealand White rabbits were exposed to 0.5 g of the test material for 24 hours under occlusive coverage upon both intact and abraded shaved skin. Subsequently, the excess material was wiped from the treated sites of the animals. Scorings were recorded 24 and 72 hours after topical application. Animals showing signs of irritation after 72 hours were further observed for signs of irritation on the seventh and tenth day after exposure. Only signs of slight erythema were observed. A primary Irritation Index of 0.1 on a scale of 0.0 to 8.0 was calculated following continous 24 -hour dermal exposure of the intact and abraded skin of six rabbits to the test item. All skin irritation had subsided by the tenth day after test material (Toluene soluble terphenyl and quarterphenyls) administration.
The daily individual, daily, mean, and 24- and 72 hour average Draize scores for the six animals are summarized below.
The Primary Irritation Index for this group of animals is 0.1 on a scale of 0.0 to 8.0. All skin irritation had subsided by the tenth day after test material administration. Defatting of the skin on all four exposed sites occurred in one animal on the tenth day after exposure. No signs of systemic toxicity were observed.
Table 1 | ||||||||||
Primary Skin Irritation to Rabbits Individual Irritation Scores | ||||||||||
Animal Number |
Period (Days) |
ERYTHEMA |
EDEMA |
|||||||
RFI |
LBI |
LFA |
RBA |
RFI |
LBI |
LFA |
RBA |
|||
01M01 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
01M02 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
01M03 |
1 |
V |
0 |
0 |
0 |
0 |
0 |
0 |
||
01F01 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
01F02 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
01F03 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
|
01M01 |
3 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
|
01M02 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
01M03 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
01F01 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
01F02 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
01F03 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
01M01 |
7 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
|
01M01 |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
RFI - Right Front Intact Patch |
RBA - Right Back Abraded Patch |
|||||||||
LBI - Left Back Intact Patch |
LFA - Left Front Abraded Patch |
Primary skin irritation score summary:
Period (days) |
Erythema |
Edema |
Irritation score |
||||
Intact |
Abraded |
Mean |
Intact |
Abraded |
Mean |
||
1 |
0.0 |
0.1 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
3 |
0.2 |
0.2 |
0.2 |
0.0 |
0.0 |
0.0 |
0.2 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Draize, J. H., Woodard, G., and Calvery, H. 0. (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J. Pharmacol. Exp. Thera p. 82: 377-390.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Terphenyl
- EC Number:
- 247-477-3
- EC Name:
- Terphenyl
- Cas Number:
- 26140-60-3
- Molecular formula:
- C18H14
- IUPAC Name:
- terphenyl
- Details on test material:
- - Name of test material: Toluene soluble terphenyl and quarterphenyls
- Physical state: brown solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Isaac's Farm, Litchfield, Illinois
- Age at study initiation: Approximately 10 weeks ( young adults)
- Weight at study initiation: 2.14-2.63 kilograms
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum (Purina Rabbit Chow O (Registered Trademark of the Ralston-Purina Company, St. Louis, Missouri))
- Water (e.g. ad libitum): ad libitum (water furnished by the City of St. Louis, Missouri)
- Acclimation period: at least five days
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A mass of 76 ± 2 mg determined to occupy a volume of 0.1 mL of test material - Duration of treatment / exposure:
- single administration
- Observation period (in vivo):
- Signs of irritation were recorded on the first, second, and third days after dosing.
- Number of animals or in vitro replicates:
- 3 animals per sex
- Details on study design:
- SCORING SYSTEM: Draize method
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.06
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- < 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- < 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 5
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks:
- .
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified
- Remarks:
- .
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified
- Remarks:
- .
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified
- Remarks:
- .
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified
- Remarks:
- .
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified
- Remarks:
- .
Any other information on results incl. tables
The individual and the 24, 48, and 72 hour average Draize scores for the six rabbit eyes treated with the test item are summarized below.
The average Draize score for this group of animals is 0.6 on a scale of 0 to 110. All irritation had subsided by the second day after exposure.
Primary Eye Irritation to Rabbits Individual Irritation Scores
Animal n° |
Obs. day |
Cornea |
Iris |
Conjunctivae |
Total |
Average of 24, 48, 72 h |
01M01 |
1 |
5 |
0 |
0 |
5 |
1.7 |
2 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
||
01M02 |
1 |
0 |
0 |
0 |
0 |
0.0 |
2 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
||
01M03 |
1 |
0 |
0 |
2 |
2 |
0.7 |
2 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
||
01F02 |
1 |
0 |
0 |
4 |
4 |
1.3 |
2 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
||
01F02 |
1 |
0 |
0 |
0 |
0 |
0.0 |
2 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
||
01F03 |
1 |
0 |
0 |
0 |
0 |
0.0 |
2 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- This key study for eye irritation is performed according to GLP and similar to OECD guideline 405, in which the Draize scoring system is used. New Zealand White rabbits were exposed to a single dose of 76 mg of the toluene soluble terphenyl and quarterphenyl test substance via the eye. Signs of irritation were recorded on the first, second and third day after dosing. Only on the first day signs of irritation were noted in 3 of the 6 test animals. By day 2, all animals were free of irritation signs.
- Executive summary:
When 76 mg (the 0.1 mL equivalent) of the test item (Toluene soluble terphenyl and quarterphenyls) was instilled into the conjunctival sac of the albino rabbit eye, the average of the Draize scores for 24, 48, and 72 hours was 0.6 on a scale of 0 to 110 for six eyes. All irritation had susided by the second day after exposure.
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