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EC number: 701-175-2 | CAS number: -
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Endpoint summary
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- 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
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- Biotransformation and kinetics
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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Endpoint summary
Administrative data
Description of key information
Skin irritation- corrosive
Eye irritation- severely irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: 49CFR, Section 173.240(a)(2)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Dutchland, Denver, Pennsylvania
- Age at study initiation: 13-18 weeks
- Weight at study initiation: not reported
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS- not reported
IN-LIFE DATES: From: June 26, 1984 To: July 31, 1984 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not applicable
VEHICLE no vehicle - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: clipped intact skin on the back
- % coverage: not reported
- Type of wrap if used: entire trunk of each animal was wrapped with a polyethylene sheet and an impervious cuff secured with adhesive tape for 4 hr.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): application sites were wiped gently with paper towels moistened with 80% (v/v) ethanol in water
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72-hr
- Score:
- 7.3
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- AVERAGE SCORE - Erythema: 4.0 - Edema: 3.3 REVERSIBILITY: no
- Other effects:
- On Day 21, severe erythema with eschar (in all rabbits) and eschar sloughing off with hair growth beneath it (in 5 of the 6 rabbits) was observed. Desiccation was also observed. On Day 28, no erythema or edema was observed. Three rabbits had hair growth over entire site with a small area that was hard to the touch. The other rabbits had possible scar formation. The one remaining rabbit's skin site appeared normal. On Day 35, no erythema or edema was observed. One rabbit had a white linear striation on the application site and possible scar formation. Four of the six rabbits had a small area that was hard to the touch and hair growth covering the entire application site.
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Based on the severe and persisting dermal reactions, and the
possible scar formation underneath the skin, the test
substance is considered corrosive to the skin of rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The purpose of this study was to evaluate whether washing with distilled water or 0.85% saline would diminish or enhance the eye irritation caused by the test material in the rabbit. One-tenth milliliter of undiluted test material was applied to the cornea of the left eye of male New Zealand White rabbits (2 rabbits per group). The treated eyes of one group of rabbits received no further treatment after dosing. The treated eyes of the remaining four groups of rabbits were irrigated with either distilled water or 0.85% saline beginning either 4 or 30 seconds after dosing. The degree of eye irritation for each animal was scored according to Draize's procedure at 24, 48, and 74 hr and at 7, 14, and 21 days.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Research Animals, Denver, pennsylvania, USA
- Age at study initiation: not reported
- Weight at study initiation: not reported
- Housing: 1/cage in stainless steel cages
- Diet (e.g. ad libitum): ad libitum; Purina laboratory rabbit chow high fiber
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 degrees C
- Humidity (%): not reported, but was monitored continuously
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: March 19, 1986 To: May 6, 1986 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Only one eye of each animal was treated; the other eye served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): none
VEHICLE not applicable, no vehicle - Duration of treatment / exposure:
- Group 6 remained unwashed; groups 7 to 10: 4 or 30 seconds
- Observation period (in vivo):
- 24, 48 and 72 hours and at 7, 14 and 21 days post exposure
- Number of animals or in vitro replicates:
- 10
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye of group 6 was unwashed. The treated eyes of groups 7 and 8 were irrigated with distilled water for 60 seconds beginning 4 or 30 seconds after dosing. The treated eyes of groups 9 and 10 were irrigated with 0.85% saline for approximately 60 seconds beginning 4 or 30 seconds after dosing.
- Time after start of exposure: 4 or 30 seconds after dosing in groups 7 to 10
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein- 2% sodium fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 37
- Max. score:
- 80
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 4.2
- Max. score:
- 10
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 19
- Max. score:
- 20
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 19.2
- Max. score:
- 80
- Remarks on result:
- other: washed for 30 sec with distilled water
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 4.2
- Max. score:
- 10
- Remarks on result:
- other: Washed for 30 sec with distilled water
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 18.3
- Max. score:
- 20
- Remarks on result:
- other: washed for 30 sec with distilled water
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 33.3
- Max. score:
- 80
- Remarks on result:
- other: washed for 30 sec with 0.85% saline
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 4.2
- Max. score:
- 10
- Remarks on result:
- other: washed for 30 sec with 0.85% saline
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 17
- Max. score:
- 20
- Remarks on result:
- other: washed for 30 sec with 0.85% saline
- Irritant / corrosive response data:
- In rabbits dosed with the test material and receiving no further treatment (i.e., unwashed eyes), both rabbits exhibited corneal, iridal, and conjunctival effects at 24 hr. Conjunctival and iridal effects were no longer present at Day 14. Corneal effects were still present by Day 21. In addition, blood vessels extending onto the cornea, blanched nictitating membrane, eschar on eyelids, bulging of the cornea, and hair loss around the treated eye were observed during the 21-day observation period. In groups receiving a distilled water or saline wash 4 seconds after treatment with the test material, both animals in each group exhibited corneal, iridal, and conjunctival effects at 24 hr. Iridal and conjunctival effects in animals washed with distilled water 4 seconds after dosing were recovered by Day 7 and 14, respectively. Iridal and conjunctival effects in animals washed with saline 4 seconds after dosing were recovered by 72 hr and Day 14, respectively. Corneal effects were present at 21 days in both groups. In addition, blood vessels extending onto the cornea, blanched nictitating membrane, hair loss around the treated eye and eyelids pinched together at corners were observed during the 21-day observation period. In groups receiving a distilled water or saline was 30 seconds after treatment with the test material, both animals in each group exhibited corneal, iridal, and conjunctival effects at 24 hr. Iridal and conjunctival effects in animals washed with distilled water 30 seconds after dosing were recovered by Day 7 and 14, respectively. Iridal and conjunctival effects in animals washed with saline 30 seconds after dosing were recovered by Day 7 and Day 21, respectively. Corneal effects were present at 21 days in both groups. In addition, circumcorneal blood vessels, blanched nictitating membrane, hair loss around eye, eschar on eyelids, bulging of the cornea, and eyelids pinched together at corners were observed during the 21-day observation period
- Other effects:
- In rabbits dosed with the test material and receiving no further treatment (i.e., unwashed eyes), blood vessels extending onto the cornea, blanched nictitating membrane, eschar on eyelids, bulging of the cornea, and hair loss around the treated eye were observed during the 21-day observation period. In groups receiving a distilled water or saline wash 4 seconds after treatment with the test material, blood vessels extending onto the cornea, blanched nictitating membrane, hair loss around the treated eye and eyelids pinched together at corners were observed during the 21-day observation period. In groups receiving a distilled water or saline was 30 seconds after treatment with the test material, circumcorneal blood vessels, blanched nictitating membrane, hair loss around eye, eschar on eyelids, bulging of the cornea, and eyelids pinched together at corners were observed during the 21-day observation period
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test material produced severe eye irritation. When
compared to unwashed treated eyes, washing with either water
or saline 4 or 30 seconds after treatment resulted in no
significant increases or decreases in the corneal, iridal,
or conjunctival effects.
- Executive summary:
The purpose of this study was to evaluate whether washing with distiled water or 0.85% saline would diminish or enhance the eye irritation caused by the test material in the rabbit. One-tenth milliliter of undiluted test material was applied tot he cornea of the left eye of male New Zealand White rabbits (2 rabbits per group). The treated eyes of one group of rabbits received no further treatment after dosing. The treated eyes of one group of rabbits received no further treatment after dosing. The treated eyes of the remaining four groups of rabbits were irrigated with either distilled water or 0.85% saline beginning either 4 or 30 seconds after dosing. The degree of eye irritation for each animal was scored according to Draize procedure at 24, 48 and 72 hr and 7, 14 and 21 days after dosing.
The test material produced severe eye irritation. When compared to unwashed treated eyes, washing with either water or saline 4 or 30 seconds after treatment resulted in no significant increase or decrease in the corneal, iridal or conjunctival effects.
Reference
Group | 6 | 6 | 7 | 7 | 8 | 8 | 9 | 9 | 10 | 10 | |
Time | Structure | Unwashed | Unwashed | 4 seconds distilled water | 4 seconds distilled water | 30 seconds distilled water | 30 seconds distilled water | 4 seconds 0.85% saline | 4 seconds 0.85% saline | 30 seconds 0.85% saline | 30 seconds 0.85% saline |
24 hours | Cornea | 20 | 40 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
24 hours | Iris | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 5 |
24 hours | Conjunctivae | 20 a | 20 a | 20 a | 20 a | 20 a | 16 a | 14 a | 20 a | 18 a | 18 a |
48 hours | Cornea | 40 | 40 | 20 | 20 | 20 | 20 | 10 | 20 | 40 | 40 |
48 hours | Iris | 5 | 2.5 | 5 | 5 | 5 | 2.5 | 0 | 2.5 | 2.5 | 5 |
48 hours | Conjunctivae | 20 a | 20 a | 18 a | 20 a | 20 a | 18 a | 12 | 16 | 14 a | 20 a |
72 hours | Cornea | 40 | 40 | 20 | 20 | 20 | 15 | 10 | 20 | 40 | 40 |
72 hours | Iris | 5 | 2.5 | 5 | 5 | 5 | 2.5 | 0 | 0 | 2.5 | 5 |
72 hours | Conjunctivae | 18 a | 18 a | 18 a | 18 | 18 a | 18 | 6 | 16 | 14 a | 20 a |
7 day | Cornea | 40 b | 40 b | 40 b | 20 b | 40 b | 0 bf | 0 k | 10 | 15 bce | 60 j |
7 day | Iris | 2.5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
7 day | Conjunctivae | 8.0 cd | 8 cd | 8 e | 4 cd | 12 acd | 4 cd | 0 | 4 | 10 | 16 acde |
14 day | Cornea | 30 bh | 15 b | 10 b | 10 b | 10 bh | 0 bi | 0 m | 0 kb | 0 bm | 60 j |
14 day | Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
14 day | Conjunctivae | 0 c | 0 c | 0 c | 0 c | 0 c | 0 c | 0 d | 0 | 0 c | 6 c |
21 day | Cornea | 20 bh | 0 f | 0 f | 10 | 10 b | 0 i | 0 m | 0 m | 0 bm | 40 l |
21 day | Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
21 day | Conjunctivae | 0 c | 0 | 0 c | 0 | 0 c | 0 | 0 c | 0 | 0 | 0 |
a a) Nictating membrane blanched b) Blood vessels approximately 1 -3 mm in length extended onto the cornea c) Hair loss around the treated eye d) Eschar on eyelids e) Eyelids pinched together at corners f) After application of 2.0% sodium fluorescein the entire cornea appeared hazy. This finding was judged to be treatment related. h) Cornea appears to bulge above the surface approximately 3 mm. i) After application of 2.0% sodium fluorescein, a 2 x 3 mm area appeared hazy in the center of the cornea. This finding was judged to be treatment related. j) Circumcorneal blood vessels approx. 1 -3 mm in length on cornea. k) After application of 2.0% sodium fluorescein a slight haze appeared on the cornea. This finding was judged to be treatment related. l) Circumcorneal blood vessels approx. 4 -6 mm in length on cornea. m) After application of 2.0% sodium fluorescein, 50% of the cornea appeared hazy. This finding was judged to be treatment related.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test material was evaluated for its potential to produce dermal irritation in New Zealand White rabbits. In the study, 0.5 ml of the undiluted test material was held under a patch covered with an impervious cuff in continuous 4-hour contact with the skin of six rabbits from which the hair had been closely clipped. Readings for irritation (erythema and edema) were made after patch removal and through either 48 hours or 14 days post application using the method of Draize, et al., 1944. Results indicate that the test material is corrosive to skin.
The test material was evaluated for its potential to produce irritation in the eyes of New Zealand White rabbits. In the study, one-tenth ml of the undiluted test material was placed into the eye of each rabbit. The ocular reactions were graded at 24 hr intervals after dosing through 7 or 21 days. In the study, satellite groups of 2 animals each received a four or 30 second wash with either distilled water or 0.85% saline solution. Irritation evaluations were made following the method of Draize et al., 1944. The test material produced severe eye irritation.
The potential of the test material to irritate skin as well as eyes and gastrointestinal mucosa upon contact indicates that this material is also likely to be irritating to the mucosa of the upper respiratory tract. Repeat-dose inhalation exposure results in irritation of the upper respiratory tract as discussed in 5.6.1.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: highly irritating
Justification for classification or non-classification
The test material is classified as corrosive based on the skin irritation/corrosion results. Severe erythema with eschar (in all rabbits) and eschar sloughing off with hair growth beneath it (in 5 of the 6 rabbits) was observed. Desiccation was also observed. Three rabbits had hair growth over entire site with a small area that was hard to the touch. The other rabbits had possible scar formation. The one remaining rabbit's skin site appeared normal. One rabbit had a white linear striation on the application site and possible scar formation. Four of the six rabbits had a small area that was hard to the touch and hair growth covering the entire application site.
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