Registration Dossier
Registration Dossier
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EC number: 915-586-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
one skin and one eye irritation study in vivo
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
- Study period:
- 5-19-1993 to 5-22-1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: EPA/OECD guideline study performed in accordance with GLP; exact details of test material (certificate of analysis, Characterisation) are not included in the report.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Six young adult, male New Zealand Albino rabbits were used for this study. The rabbits were obtained from Oak Hill, Holland, Michigan, and weighed between 2.30 and 2.71 kg at study initiation. The rabbits were identified by ear tags and were individually housed in stainless steel cages in a temperature, humidity and light-controlled room in our AAALAC accredited facility (rm. 14). The animals were maintained according to the recommendations contained in the DHHS Publication No. 86-23 (NIH): Revised 1985, "Guide for the Care and Use of Laboratory Animals." They were conditioned for five days prior to the initiation of the study. Purina Rabbit Chow (ca. 350 gm) was placed in the feeders each morning during the study. Tap water from an automatic watering system was available ad libitum from arrival until termination. Six animals were selected randomly from the acclimated colony and assigned to the test group. The animals used for this study were considered to be in good health at study initiation.
Justification for Selection of Test System: The New Zealand Albino rabbit has been used extensively as an animal model for skin irritation testing. - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of undiluted test material.
- Duration of treatment / exposure:
- 4 hours.
- Observation period:
- Rabbits were weighed at the initiation and termination of the study. Dermal irritation readings were performed approximately 30 minutes after patches were removed (4.5 hours), as well as 24, 48 and 72 hours after treatment.
- Number of animals:
- 6 animals.
- Details on study design:
- Twenty four hours prior to study initiation, electric clippers were used to remove the hair from an 8 x 8 cm area located on the left flank of each animal. 0.5 grams of the test material was flattened into a wafer and applied to the intact site of each rabbit. The test material was then covered with a 4 x 4 gauze pad and the entire trunk wrapped with 4 mil plastic wrap. The ends of the plastic wrap were then sealed with surgical tape. The covering material was removed after a four hour contact period, and excess test material was wiped from the site. The study was terminated at the end of 4 days.
- Irritation parameter:
- erythema score
- Basis:
- animal: Mean score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: unabraded sites
- Irritation parameter:
- edema score
- Basis:
- animal: Mean score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: unabraded sites
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the results of this study the test material, Automate Yellow 8 Petroleum, produced a Primary Irritation Index of 0/8.00 and would be considered non-irritating to the skin of the rabbit. Based on the mean scores for the 24, 48 and 72 hr time-points for each animal, this material would not be classified under the GHS system of classification.
- Executive summary:
Automate Yellow 8 Petroleum (0.5 g) was applied to an unabraded site on the shaved left flank of each of six male albino rabbits for a four hour contact period. The application sites were graded for skin irritation at 4.5, 24, 48 and 72 hours after compound administration. There was no irritation observed in any of the six animals thoughout the study. The Primary Irritation Index, based upon 4.5,24,48 and 72 hour scores, was 0/8.00. Based upon the results of this study the test material, Automate Yellow 8 Petroleum, produced a Primary Irritation Index of 0/8.00 and would be considered non-irritating to the skin of rabbits. Based on the mean scores for the 24, 48 and 72 hr time-points for each animal, this material would not be classified under the GHS system of classification.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Grading and scoring of irritation were performed in accordance with the Draize scoring system (Appendix 1). Individual and group mean body weights as well as individual and mean primary skin irritation scores for the test material are presented in Appendix 2. There was no irritation observed in any of the six animals thoughout the study. The Primary Irritation Index, based upon 4.5, 24, 48 and 72 hour scores, was 0/8.00.
APPENDIX 2: INDIVIDUAL AND MEAN PRIMARY SKIN IRRITATION SCORES (Unabraded sites)
Animal # |
Initial Weight (kg) |
Final Weight (Kg) |
4.5 Hours |
24 Hours |
48 Hours |
72 Hours |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|||
435 |
2.30 |
2.35 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
441 |
2.33 |
2.40 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
448 |
2.54 |
2.59 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
449 |
2.31 |
2.44 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
452 |
2.55 |
2.57 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
454 |
2.71 |
2.78 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean +SD |
2.46 0.17 |
2.52 0.16 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Daily Mean Primary Irritation Score (=er+ed) |
0 |
0 |
0 |
0 |
||||||
Primary Irritation Index (4.5, 24, 48 and 72 hrs/4) |
0 |
|||||||||
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
- Study period:
- 5-28-1993 to 5-31-1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: EPA/OECD guideline study performed in accordance with GLP; exact details of test material (certificate of analysis, Characterisation) are not included in the report.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- One group of six male New Zealand White rabbits were used for this study. The rabbits were obtained from Oak Hill, Holland, Michigan, and weighed between 2.24 and 2.85 kg. at study initiation.
The rabbits were identified by ear tags and were individually housed in stainless steel cages in a temperature, humidity, and light controlled room. The animals were maintained according to the recommendations contained in DHHS Publication No. 86-23 (NIH): Revised 1985, "Guide for the Care and Use of Laboratory Animals." They were conditioned for 5 days prior to study initiation. Purina Rabbit Chow (ca. 350 gm) was placed in the feeders each morning during the study. Tap water from an automatic watering system was provided ad libitum from arrival until termination. Six animals were selected randomly from the acclimated colony and assigned to the test group.
Justification for Selection of Test System: The New Zealand Albino rabbit has been used extensively for eye irritation evaluations. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye served as the untreated control for each rabbit.
- Amount / concentration applied:
- 0.1 g of undiluted test material.
- Duration of treatment / exposure:
- Single exposure.
- Observation period (in vivo):
- The treated eyes were examined and scored at 1, 24, 48 and 72 hours after treatment. A solution of 2% sodium fluorescein and ultraviolet light were employed to reveal possible corneal injury. Scoring was performed in accordance with the Draize Scale For Scoring Ocular Lesions (Table 1).
- Number of animals or in vitro replicates:
- 6 animals.
- Details on study design:
- The test material (0.1 g) was flattened into a small wafer and was instilled into the conjunctival sac of the right eye of each rabbit, and the eyelids were held together for one second.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: Mean score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal: Mean score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: Mean score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0.28
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal: Mean score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Conjunctival irritation was observed in 4/6 of the treated eyes at the 1 hour and 24 hour observation. The maximum group mean irritation score was 2.0/110.0 and occurred at the 1 hour observation. This score decreased to 0 by 72 hours post-instillation. Automate Yellow 8 Petroleum would be classified as Toxicity Category III for eye effects in accordance with EPA regulations. Based on the mean scores for the 24, 48 and 72 hr time-points for each animal, this material would not be classified under the GHS system of classification.
- Executive summary:
Automate Yellow 8 Petroleum was instilled into the conjunctival sac of the right eye of six New Zealand Albino rabbits at a dose of 0.1 g. The eyes were observed and scored at 1, 24, 48 and 72 hours after treatment.
Conjunctival irritation was observed in 4/6 of the treated eyes at the 1 hour and 24 hour observations. Conjunctival irritation was observed in 1/6 animals at the 48 hour observation. The maximum group mean score was 2.0/110.0 and occurred at the 1 hour observation. This score decreased to 0 by 72 hours post-instillation.
Therefore, Automate Yellow 8 Petroleum would be classified as Toxicity Category III for eye effects in accordance with EPA regulations.
Based on the mean scores for the 24, 48 and 72 hr time-points for each animal, this material would not be classified under the GHS system of classification.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Table 2: INDIVIDUAL AND GROUP MEAN BODY WEIGHTS
Animal # |
Initial Weight (kg) |
Final Weight (kg) |
432 |
2.62 |
2.58 |
438 |
2.68 |
2.73 |
442 |
2.24 |
2.32 |
446 |
2.53 |
2.59 |
447 |
2.47 |
2.47 |
451 |
2.85 |
2.79 |
Mean |
2.57 |
2.58 |
+SD |
0.21 |
0.17 |
Table 3: INDIVIDUAL EYE IRRITATION SCORES
Animal # 432 |
Observation (Hours) |
||||
1 |
24 |
48 |
72 |
||
Cornea |
A. Opacity |
0 |
0 |
0 |
0 |
|
B. Area |
0 |
0 |
0 |
0 |
|
Subtotal (AxBx5) |
0 |
0 |
0 |
0 |
Iris |
A. Iris |
0 |
0 |
0 |
0 |
|
Subtotal (Ax5) |
0 |
0 |
0 |
0 |
Conjunctiva |
A. Erythema |
1 |
1 |
0 |
0 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
|
C. Discharge |
0 |
0 |
0 |
0 |
|
Subtotal (A+B+C)x2 |
2 |
2 |
0 |
0 |
Animal # 438 |
Observation (Hours) |
||||
1 |
24 |
48 |
72 |
||
Cornea |
A. Opacity |
0 |
0 |
0 |
0 |
|
B. Area |
0 |
0 |
0 |
0 |
|
Subtotal (AxBx5) |
0 |
0 |
0 |
0 |
Iris |
A. Iris |
0 |
0 |
0 |
0 |
|
Subtotal (Ax5) |
0 |
0 |
0 |
0 |
Conjunctiva |
A. Erythema |
1 |
1 |
0 |
0 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
|
C. Discharge |
1 |
1 |
0 |
0 |
|
Subtotal (A+B+C)x2 |
4 |
4 |
0 |
0 |
Animal # 442 |
Observation (Hours) |
||||
1 |
24 |
48 |
72 |
||
Cornea |
A. Opacity |
0 |
0 |
0 |
0 |
|
B. Area |
0 |
0 |
0 |
0 |
|
Subtotal (AxBx5) |
0 |
0 |
0 |
0 |
Iris |
A. Iris |
0 |
0 |
0 |
0 |
|
Subtotal (Ax5) |
0 |
0 |
0 |
0 |
Conjunctiva |
A. Erythema |
1 |
1 |
0 |
0 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
|
C. Discharge |
1 |
0 |
0 |
0 |
|
Subtotal (A+B+C)x2 |
4 |
2 |
0 |
0 |
Animal # 446 |
Observation (Hours) |
||||
1 |
24 |
48 |
72 |
||
Cornea |
A. Opacity |
0 |
0 |
0 |
0 |
|
B. Area |
0 |
0 |
0 |
0 |
|
Subtotal (AxBx5) |
0 |
0 |
0 |
0 |
Iris |
A. Iris |
0 |
0 |
0 |
0 |
|
Subtotal (Ax5) |
0 |
0 |
0 |
0 |
Conjunctiva |
A. Erythema |
0 |
0 |
0 |
0 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
|
C. Discharge |
0 |
0 |
0 |
0 |
|
Subtotal (A+B+C)x2 |
0 |
0 |
0 |
0 |
Animal # 447 |
Observation (Hours) |
||||
1 |
24 |
48 |
72 |
||
Cornea |
A. Opacity |
0 |
0 |
0 |
0 |
|
B. Area |
0 |
0 |
0 |
0 |
|
Subtotal (AxBx5) |
0 |
0 |
0 |
0 |
Iris |
A. Iris |
0 |
0 |
0 |
0 |
|
Subtotal (Ax5) |
0 |
0 |
0 |
0 |
Conjunctiva |
A. Erythema |
1 |
1 |
1 |
0 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
|
C. Discharge |
0 |
0 |
0 |
0 |
|
Subtotal (A+B+C)x2 |
2 |
2 |
2 |
0 |
Animal # 451 |
Observation (Hours) |
||||
1 |
24 |
48 |
72 |
||
Cornea |
A. Opacity |
0 |
0 |
0 |
0 |
|
B. Area |
0 |
0 |
0 |
0 |
|
Subtotal (AxBx5) |
0 |
0 |
0 |
0 |
Iris |
A. Iris |
0 |
0 |
0 |
0 |
|
Subtotal (Ax5) |
0 |
0 |
0 |
0 |
Conjunctiva |
A. Erythema |
0 |
0 |
0 |
0 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
|
C. Discharge |
0 |
0 |
0 |
0 |
|
Subtotal (A+B+C)x2 |
0 |
0 |
0 |
0 |
Table 4: GROUP MEAN EYE IRRITATION SCORES
Animal # |
Tissue |
Observation (Hours) |
|||
1 |
24 |
48 |
72 |
||
432 |
Cornea (AxBx5) |
0 |
0 |
0 |
0 |
Iris (Ax5) |
0 |
0 |
0 |
0 |
|
Conjunctiva (A + B + C)x2 |
2 |
2 |
0 |
0 |
|
Total |
2 |
2 |
0 |
0 |
|
|
|||||
438 |
Cornea (AxBx5) |
0 |
0 |
0 |
0 |
Iris (Ax5) |
0 |
0 |
0 |
0 |
|
Conjunctiva (A + B + C)x2 |
4 |
4 |
0 |
0 |
|
Total |
4 |
4 |
0 |
0 |
|
|
|||||
442 |
Cornea (AxBx5) |
0 |
0 |
0 |
0 |
Iris (Ax5) |
0 |
0 |
0 |
0 |
|
Conjunctiva (A + B + C)x2 |
4 |
2 |
0 |
0 |
|
Total |
4 |
2 |
0 |
0 |
|
|
|||||
446 |
Cornea (AxBx5) |
0 |
0 |
0 |
0 |
Iris (Ax5) |
0 |
0 |
0 |
0 |
|
Conjunctiva (A + B + C)x2 |
0 |
0 |
0 |
0 |
|
Total |
0 |
0 |
0 |
0 |
|
|
|||||
447 |
Cornea (AxBx5) |
0 |
0 |
0 |
0 |
Iris (Ax5) |
0 |
0 |
0 |
0 |
|
Conjunctiva (A + B + C)x2 |
2 |
2 |
2 |
0 |
|
Total |
2 |
2 |
2 |
0 |
|
|
|||||
451 |
Cornea (AxBx5) |
0 |
0 |
0 |
0 |
Iris (Ax5) |
0 |
0 |
0 |
0 |
|
Conjunctiva (A + B + C)x2 |
0 |
0 |
0 |
0 |
|
Total |
0 |
0 |
0 |
0 |
|
|
|||||
Group Mean |
Cornea |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
|
Conjunctiva |
2.0 |
1.7 |
0.3 |
0 |
|
Total |
2.0 |
1.7 |
0.3 |
0 |
|
|
|||||
Cornea A =density
B =area
Corneal score = (AxBx5)
Maximum score = 80
Iris Iris score = (Ax5)
Maximum score = 10
Conjunctiva A = erythema
B =chemosis
C = discharge
Conjunctival score = (A+B+C) X 2
Maximum score = 20
Total Maximum Score = 110.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
Automate Yellow 8 Petroleum (0.5 g) was applied to an unabraded site on the shaved left flank of each of six male albino rabbits for a four hour contact period. The application sites were graded for skin irritation at 4.5, 24, 48 and 72 hours after compound administration. There was no irritation observed in any of the six animals thoughout the study. The Primary Irritation Index, based upon 4.5,24,48 and 72 hour scores, was 0/8.00. Based upon the results of this study the test material, Automate Yellow 8 Petroleum, produced a Primary Irritation Index of 0/8.00 and would be considered non-irritating to the skin of rabbits. Based on the mean scores for the 24, 48 and 72 hr time-points for each animal, this material would not be classified under the GHS system of classification.
Eye irritation:
Automate Yellow 8 Petroleum was instilled into the conjunctival sac of the right eye of six New Zealand Albino rabbits at a dose of 0.1 g. The eyes were observed and scored at 1, 24, 48 and 72 hours after treatment.
Conjunctival irritation was observed in 4/6 of the treated eyes at the 1 hour and 24 hour observations. Conjunctival irritation was observed in 1/6 animals at the 48 hour observation. The maximum group mean score was 2.0/110.0 and occurred at the 1 hour observation. This score decreased to 0 by 72 hours post-instillation.
Therefore, Automate Yellow 8 Petroleum would be classified as Toxicity Category III for eye effects in accordance with EPA regulations.
Based on the mean scores for the 24, 48 and 72 hr time-points for each animal, this material would not be classified under the GHS system of classification.
Justification for selection of skin irritation / corrosion
endpoint:
reliable in vivo study
Justification for selection of eye irritation endpoint:
reliable in vivo study
Justification for classification or non-classification
this substance does not require classification for irritation (skin and eye) according to CLP
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