Registration Dossier
Registration Dossier
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EC number: 810-258-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Available read-across data support the conclusion that the registered substance is not irritating for skin or eye.
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: USEPA Pesticide Assessment Guidelines (540/9-82-025)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 100%
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 21 days
- Number of animals:
- 6
- Details on study design:
- The study was conducted on six New Zealand White rabbits, 3 male and 3 female, to determine the skin irritation potential of the test material. The animals were individually housed, equilibrated in the laboratory, and released from quarantine prior to testing. Normal growth, appearance, and behavior during the equilibration period were factors used to select healthy animals for testing.
Each animal was prepared on the day prior to treatment by clipping the dorsal area of the trunk free of hair to expose an area at least eight centimeters by eight centimeters. Care was taken to avoid abrading the skin. Only those animals with exposure areas free from pre-existing skin irritation or defects were selected for testing.
There was one intact skin test site per animal. East test site was treated with 0.5 milliliters of actual undiluted test material by introducing the test material at room temperature beneath a surgical gauze patch measuring 1 inch x 1 inch and two single layers thick. Each patch was secured in place with a strip of a non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) to retard evaporation of volatile substances and to prevent the animals from possibly ingesting any of the test material. To secure the wrappings in place, the edges of the dressing were wrapped with a non-irritating adhesive tape in a manner which would not cdause discomfort to the animals. The animals were then returned to their cages.
Four hours after treatment the wrapping, tape, and gause patches were removed. The backs of the animals were gently washed with room temperature tap water and a wet cloth to remove as much residual test material as possible. The animals were observed for erythema and eschar formation, edema formation, and any other dermal defects or irritation at 0, 24, 48, and 72 hours and on Days 7, 9, 13, 17, and 20 (Day 0 considered day of treatment) after washing.
For each observation time, all of the erythema and edema scores were added, and the sum was divided by the number of animals observed to determine an irritation score. The maximum irritation score was selected from the observation time yielding the highest irritation score. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- ca. 0 - 4.2
- Max. score:
- 4.2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 20 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 9 days
- Irritant / corrosive response data:
- Erythema was present at each observation time through Day 17. Edema was present at each observation time through Day 7. The maximum irritation score of 4.2 our of a possible 8.0 was obtained at the one hour observation.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Reported skin irritation results for the test animals do not meet the criteria for irritant or mild irritant under GHS.
- Executive summary:
The study was conducted on six New Zealand White rabbits, 3 male and 3 female, to determine the skin irritation potential of the test material. The animals were individually housed, equilibrated in the laboratory, and released from quarantine prior to testing. Normal growth, appearance, and behavior during the equilibration period were factors used to select healthy animals for testing.
Each animal was prepared on the day prior to treatment by clipping the dorsal area of the trunk free of hair to expose an area at least eight centimeters by eight centimeters. Care was taken to avoid abrading the skin. Only those animals with exposure areas free from pre-existing skin irritation or defects were selected for testing.
There was one intact skin test site per animal. East test site was treated with 0.5 milliliters of actual undiluted test material by introducing the test material at room temperature beneath a surgical gauze patch measuring 1 inch x 1 inch and two single layers thick. Each patch was secured in place with a strip of a non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) to retard evaporation of volatile substances and to prevent the animals from possibly ingesting any of the test material. To secure the wrappings in place, the edges of the dressing were wrapped with a non-irritating adhesive tape in a manner which would not cdause discomfort to the animals. The animals were then returned to their cages.
Four hours after treatment the wrapping, tape, and gause patches were removed. The backs of the animals were gently washed with room temperature tap water and a wet cloth to remove as much residual test material as possible. The animals were observed for erythema and eschar formation, edema formation, and any other dermal defects or irritation at 0, 24, 48, and 72 hours and on Days 7, 9, 13, 17, and 20 (Day 0 considered day of treatment) after washing. For each observation time, all of the erythema and edema scores were added, and the sum was divided by the number of animals observed to determine an irritation score.
Erythema was present at each observation time through Day 17. Edema was present at each observation time through Day 7. The maximum irritation score of 4.2 our of a possible 8.0 was obtained at the one hour observation.
Reported skin irritation results for the test animals do not meet the criteria for irritant or mild irritant under GHS.
Reference
Observation Time |
ERYTHEMA FORMATION |
EDEMA FORMATION |
OTHER OBSERVATIONS |
IRRITATION SCORE |
|||||||||||||||
Rabbit Number |
Rabbit Number |
Rabbit Number |
|||||||||||||||||
1M |
2M |
3M |
4F |
5F |
6F |
1M |
2M |
3M |
4F |
5F |
6F |
1M |
2M |
3M |
4F |
5F |
6F |
||
0 Hours |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
4.2 |
24 Hours |
2 |
1 |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
3.2 |
48 Hours |
2 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2.3 |
72 Hours |
2 |
1 |
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2.5 |
Day 7 |
1 |
1 |
3 |
1 |
1 |
1 |
0 |
0 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1.8 |
Day 9 |
0 |
0 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
S |
S |
S |
S |
S |
S |
0.5 |
Day 13 |
0 |
0 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
S |
S |
S |
S |
S |
S |
0.5 |
Day 17 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
S |
0 |
0 |
S |
S |
0.2 |
Day 20 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
S |
0.0 |
Maximum Irritation Score = 4.2
M – Male; F – Female
S – Sloughing of skin of various thicknesses
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
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: Well conducted study for read-across substance performed according to established protocol.
- Qualifier:
- according to guideline
- Guideline:
- other: Lehman, A.J. et al., in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc., Food and Drug Officials of the U.S., Second Printing, Topeka, Kansas 1965
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 100%
- Duration of treatment / exposure:
- One-time treatment of one eye per rabbit
- Observation period (in vivo):
- Test animals observed at 1, 24, 48, and 72-hour, and 7 days.
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- Six New Zealand albino rabbits were used to determine the degree of ocular irritation resulting from the addition of the test material, Conoco LPA Solvent 8558-G, into the conjunctival sac of the animals.
The animals were individually housed in metal cages elevated above the droppings with feed, consisting of Purina Rabbit Chow and tap water freely available at all times.
Both eyes of each animals were examined with Fluoroscein Sodium Ophthalmic solution U.S.P. 4 hours before testing and only those animals without observable eye defects or irritation were used.
One-tenth milliliter of the test material was placed in one eye of each animals by gently pulling the lower lid away from the eyeball to form a cup into which the test material was deposited. The lids were then gently held together for one second and the animals was released. The other eye was not treated and served as a control. The eyes were not washed following instillation of the test material except as noted below. All animals were immobilized in a suitable animal restrainer for 1 hour subsequent to treatment.
The eyes were examined and the grade of ocular reaction was recorded at 1, 24, 48 and 72 hours and at 7 days, using the scale for scoring ocular lesions as outlined by Lehman, A.J. et al., in Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics Assoc., Food and Drug Officials of the U.S., Second Printing, Topeka, Kansas 1965. The evaluation of the data was in accordance with Section 191.12 Chapter 1, Title 21, Code of Federal Regulations under the FHSA.
After the initial examination at 24 hours all eyes were washed with sufficient clean tap water at body temperature to remove the residual test sample. All eyes were further examined by placing one drop of Fluorescein Sodium Ophthalmic solution U.S.P. on the cornea. After 5 minutes the excess fluoroscein was flushed out with sufficient tap water. Injured areas of the cornea appeared greenish yellow following application of fluoroscein. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- >= 0 - <= 5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Within one hour, barely perceptible erythema of the palpebral and bulbar conjunctivae, chemosis of the lids and an accumulation of watery discharge (3 animals only). The erythema and discharge did not last 24 hours. The chemosis was present at a barely perceptible level in three test eyes for 72 hours. All animals were normal by 7 days. A maximum average score of 5.0 was recorded at 1 hour.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Reported results of cornea, iris, and conjunctivae scores for all six test animals do not meet the criteria for classification as an irritant.
- Executive summary:
Conoco LPA Solvent 8558 -G, when instilled undiluted into the conjunctival sac of six New Zealand albino rabbits and the treated eyes not washed following instillation of the test material, produced, within 1 hour, a barely perceptible to slight erythema, chemosis and water discharge (3 of 6 animals). This showed improvement throughout the study period. By 24 hours, the erythema had disappeared and only chemosis remained (5 of 6). By 72 hours only a barely perceptible chemosis remained in 3 of 6 test eyes. At 7 days, all test eyes were normal.
Mean corneal opacity, iritis, and conjuctivae scores for the test animals averaged over 24, 48, and 72 hours were insufficient to classify; therefore, the test material is considered not irritating.
Reference
RESULTS:
Rabbit No. |
Structure |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
7 Days |
1 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
6 |
2 |
2 |
0 |
0 |
|
2 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
4 |
2 |
0 |
0 |
0 |
|
3 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
4 |
0 |
0 |
0 |
0 |
|
4 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
6 |
2 |
2 |
2 |
0 |
|
5 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
4 |
2 |
0 |
0 |
0 |
|
6 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
6 |
2 |
2 |
2 |
0 |
|
Average |
5.0 |
1.7 |
1.0 |
0.7 |
0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Reported read-across data support the conclusion that the registered substance is not irritating for skin or eye when compared against GHS criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
