Registration Dossier
Registration Dossier
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EC number: 275-269-2 | CAS number: 71215-81-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987 November 3 to 6
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1981)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-amino-2-chloro-N-(2,4-dimethylphenyl)benzenesulphonamide
- EC Number:
- 275-269-2
- EC Name:
- 5-amino-2-chloro-N-(2,4-dimethylphenyl)benzenesulphonamide
- Cas Number:
- 71215-81-1
- Molecular formula:
- C14H15ClN2O2S
- IUPAC Name:
- 5-amino-2-chloro-N-(2,4-dimethylphenyl)benzene-1-sulfonamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- Description: brown coloured lumpy powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K. and Rosemead Rabbits, Ilaltham Abbey, Essex, U.K
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.42-2.76 kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet (e.g. ad libitum): Free access to mains drinking water and food (Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K. ) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water and food (Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K. ) was allowed throughout the study.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 48-50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
VEHICLE
A quantity of 0.5g of the test material moistened with 0.5 m1 of distilled water was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin.
- Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The patch was secured in position over the test material with a strip of surgical adhesfve tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals from interfering with the patches the trunk of each rabbit was wrapped in an elasticated
corset (TUBIGRIP)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 1; 24; 48 & 72h after removal of the patches
SCORING SYSTEM:
- Method of calculation: Draize (1959) in the original report.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1; 2 & 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1d (score of 1 observed after 1h in 3/3 animals)
- Irritation parameter:
- edema score
- Basis:
- animal: #1; 2 & 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1d (score of 1 observed after 1h in 2/3 animals)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- ACDMA is non-irritant to rabbit skin in in vivo test performed according to OECD TG 404 & GLP following CLP criteria.
- Executive summary:
ACDMA is non-irritant to rabbit skin in in vivo test performed according to OECD TG 404 & GLP following CLP criteria.
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