Registration Dossier
Registration Dossier
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EC number: 250-701-2 | CAS number: 31565-19-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- An existing in vivo skin irritation / corrosivity study was available for the test substance.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 October 1983 - 25 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:
- 1984
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:
- Isooctyl acetate
- EC Number:
- 250-701-2
- EC Name:
- Isooctyl acetate
- Cas Number:
- 31565-19-2
- Molecular formula:
- C10H20O2
- IUPAC Name:
- Acetic acid, isooctyl ester
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Exxon chemical company
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room termperature
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 17 weeks
- Weight at study initiation: 2.61 to 3.57 kg
- Housing: Individual, suspended stainless steel, no bedding
- Diet (e.g. ad libitum): purina rabbit chow HF (pellets), ad libitum
- Water (e.g. ad libitum): Automatic watering system, ad libitum
- Acclimation period: 42 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21 °C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12 hr light/dark
IN-LIFE DATES: From: 16 October 1983 To: 25 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 - Duration of treatment / exposure:
- 4 hr
- Observation period:
- 30, 60 minutes, 24, 48, 72 hours, 7 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1x1 inch
- Type of wrap if used: Gauze patch, then secured with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
- Time after start of exposure: 4 hr
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 60 min, 24, 48, 72 hr and 7 days
SCORING SYSTEM:
- Method of calculation: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 60 min
- Score:
- 1.16
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.83
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.83
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.83
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0.33
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.16
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.16
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 60 min
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 60 min
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 60 min
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 60 min
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 60 min
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 60 min
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hr
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hr
- Irritant / corrosive response data:
- Positive dermal scores were recorded for all animals at the 60 minute interval. By the day 7 observation 4 of the 6 animals were clear of any signs of irritation.
Based upon these findings the primary irritation index was 0.92
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Slight to moderate erythema was observed after 30-60 mins which was reversible in all animals by day 7. Under the coniditions of the study the test chemical is not classified as a skin irritant.
- Executive summary:
The primary dermal irritation potential of MRD-83-303 has evaluated in rabbits following topical occlusive exposure. The test material has applied as a single
dose of 0.5 ml to a single site on the clipped backs of 3 male and 3 female rabbits. The test material remained in contact with the intact skin of all
animals for a period of 4 hours. After exposure was completed the plastic sleeves and gauze were removed and the test site was graded for erythema, edema and other signs of dermal irritation at 30 to 60 minutes, 24, 48 and 72 hours following patch removal. Dermal readings were also performed on day 7. All Dermal scoring was performed according to the Draize method of scoring.
Positive dermal scores were recorded for all animals at the 60 minute interval. By the day 7 observation 4 of the 6 animals were clear of any signs of irritation.
Based upon these findings the primary irritation index was 0.92.
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