Registration Dossier
Registration Dossier
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EC number: 600-872-8 | CAS number: 108419-35-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- An existing in vivo ski irritation / corrosivity study was available.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 August 1983 to 18 October 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Acetic acid, C11-14-isoalkyl esters, C13-rich
- EC Number:
- 283-740-9
- EC Name:
- Acetic acid, C11-14-isoalkyl esters, C13-rich
- Cas Number:
- 84712-50-5
- Molecular formula:
- C15H30O2
- IUPAC Name:
- Acetic acid, C11-14-isoalkyl esters, C13-rich
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Exxon biomedical sciences inc.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton dutchland inc, Denver PA
- Age at study initiation: Approximately 22 weeks
- Weight at study initiation: 3.06 to 3.5 kg
- Housing: Individual, Steel housing
- Diet (e.g. ad libitum): Purina Rabbit chow HF, ab libitum
- Water (e.g. ad libitum): Automatic watering system, ab libitum
- Acclimation period: 71 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21 °C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
IN-LIFE DATES: From: 1 August 1983 to 18 October 1983
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Assumed 100%
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 min, 24, 48, 72 hour, 7 day
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal surface from the shoulder region to the lumbar region
- % coverage: 5 % of total body
- Type of wrap if used: Gauze patch and plastic sleeve
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 60 min, 24, 48, 72 hour, 7 day
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 60 min
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 60 m
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 60 m
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 60 min
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 60 m
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- Dermal exposure to MRD-83-308 elicited very slight (barely perceptible) erythema in all animals. Positive dermal irritation scores were recorded for all animals at the 24 hour observation interval. By the day 7 readings only 1 animal continued to show signs of dermal irritation.
The primary irritation index for the 24 and 72 hour observations were calculated to be 0.67. - Other effects:
- There were no deaths noted during this study. Five of the 6 test animals displayed an increase in body weight during the 7 day test period.
Any other information on results incl. tables
Results tables can be found in the attachment to this RSS.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dermal exposure to MRD-83-308 elicited very slight (barely perceptible) erythema in all animals. Positive dermal irritation scores were recorded for all animals at the 24 hour observation interval. By the day 7 readings only 1 animal continued to show signs of dermal irritation.
The primary irritation index for the 24 and 72 hour observations were calculated to be 0.67. - Executive summary:
The primary skin irritation potential of MRD-83-306 was evaluated following its application to the clipped backs of six New Zealand white rabbits. The test material was topically administered to an intact site on the back of each animal, covered with gauze and secured with a plastic sleeve for 4 hours. After exposure was completed the plastic sleeve and gauze were removed and the test site was graded for erythema, edema and other signs of dermal irritation at approximately 60 minutes, 24, 48 and 72 hours following patch removal. Dermal readings were also made on day 7. All dermal scoring was made according to the Draize method of scoring.
Dermal exposure to MRD-83-306 elicited very slight (barely perceptible) erythema for all animals at the 24 hour observation interval. Only one animal showed signs of dermal irritation through to day 7.
Based on these findings the primary irritation index was 0.67. The primary skin irritation potential of MRD-83-306 was evaluated following its application to the clipped backs of six New Zealand white rabbits. The test material was topically administered to an intact site on the back of each animal, covered with gauze and secured with a plastic sleeve for 4 hours. After exposure was completed the plastic sleeve and gauze were removed and the test site was graded for erythema, edema and other signs of dermal irritation at approximately 60 minutes, 24, 48 and 72 hours following patch removal. Dermal readings were also made on day 7. All dermal scoring was made according to the Draize method of scoring.
Dermal exposure to MRD-83-306 elicited very slight (barely perceptible) erythema for all animals at the 24 hour observation interval. Only one animal showed signs of dermal irritation through to day 7.
Based on these findings the primary irritation index was 0.67.
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