Registration Dossier
Registration Dossier
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EC number: 610-420-1 | CAS number: 483965-67-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well performed GLP complient study which meets the requirements of OECD Guideline 404 and EU Method B.4 (84/449/EEC) The read-across substance shares the functional group, arylsulfonylchloride. Corrosive/Irritating effects are attributed to the compounds generated by hydrolysis, i.e. hydrochloric acid and arylsulfonic acid.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 84/449/EEC
- Deviations:
- no
- Principles of method if other than guideline:
- Although the test substance was not moistened with water a good skin contact was ensured by the consistency of the substance and was proven by the significant skin reaction observed.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-acetamido-5-methoxy-2-methylbenzenesulphonyl chloride
- EC Number:
- 268-233-2
- EC Name:
- 4-acetamido-5-methoxy-2-methylbenzenesulphonyl chloride
- Cas Number:
- 68039-14-5
- IUPAC Name:
- 4-acetamido-5-methoxy-2-methylbenzenesulfonyl chloride
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland GmbH, 88353 Kißlegg
- Weight at study initiation: 2.1 kg to 3.9 kg
- Housing: in fully air-conditioned rooms in separate cages
- Diet (e.g. ad libitum): standard laboratory diet (ssniff K-H V2333) ad libitum, appr. approx. 15 g hay daily
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (air-condition)
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Although the test substance was not moistened with water a good skin contact was ensured by the consistency of the substance and was proven by the significant skin reaction observed.
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Duration of treatment / exposure:
- 4 hours as well as 3 minutes
- Observation period:
- 14 days
- Number of animals:
- 6; 2 treatment groups with 3 animals respectively
- Details on study design:
- TEST SITE
- about 24 hours before the start of the study the hair in the dorsal region of the body of the rabbits was removed with an electric clipper over an area of about 25 cm2.
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: cellulose patch on a piece of surgical plaster (Beiersdorf AG) covered with a semi-occlusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with warm tap water
- Time after start of exposure: 4 hours or 3 minutes respectively
SCORING SYSTEM:
DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: # 80
- Time point:
- other: mean of the 24, 48 and 72 h readings
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: 4 hour treatment group
- Irritation parameter:
- erythema score
- Basis:
- animal: # 90
- Time point:
- other: mean of the 24, 48 and 72 h readings
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: grade 1 after 20 - 60 min was fully reversible after 1 day
- Remarks on result:
- other: 4 hour treatment group
- Irritation parameter:
- erythema score
- Basis:
- animal: # 91
- Time point:
- other: mean of the 24, 48 and 72 h readings
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: the observation period of 7 days
- Remarks on result:
- other: 4 hour treatment group
- Irritation parameter:
- edema score
- Basis:
- animal: # 80, # 90 each
- Time point:
- other: mean of the 24, 48 and 72 h readings
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect occured
- Remarks on result:
- other: 4 hour treatment group
- Irritation parameter:
- edema score
- Basis:
- animal: # 91
- Time point:
- other: mean of the 24, 48 and 7s h readings
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: 4 hour treatment group
- Irritation parameter:
- erythema score
- Basis:
- animal: # 164
- Time point:
- other: mean of the 24, 48 and 72 h readings
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 3 minutes treatment group
- Irritation parameter:
- erythema score
- Basis:
- animal: # 165
- Time point:
- other: mean of the 24, 48 and 72 h readings
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevent since no effect occured
- Remarks on result:
- other: 3 minutes treatment group
- Irritation parameter:
- erythema score
- Basis:
- animal: # 166
- Time point:
- other: mean of the 24, 48 and 72 h readings
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 3 minutes treatment group
- Irritation parameter:
- edema score
- Basis:
- animal: # 164
- Time point:
- other: mean of the 24, 48 and 72 h readings
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 3 minutes treatment group
- Irritation parameter:
- edema score
- Basis:
- animal: # 165
- Time point:
- other: mean of the 24, 48 and 72 h readings
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect occured
- Remarks on result:
- other: 3 minutes treatment group
- Irritation parameter:
- edema score
- Basis:
- animal: # 166
- Time point:
- other: mean of the 24, 48 and 72 h readings
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: 3 minutes treatment group
- Irritant / corrosive response data:
- animal # 91 (4 hour treatment group):
The skin surface was parchment-like, dry-rough, fine scaled and small discolored beige. 7 days after removal of the plaster a scar was noted.
animal # 164 (3 minutes treatment group):
The skin surface was encrusted, indurated and small discolored brown. 14 days after removal of the plaster a scar was noted.
animal # 166 (3 minutes treatment group):
The skin surface was dry-rough and fine scaled. - Other effects:
- no other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the findings in this study the test substance has to be classified as corrosive, category 1B, according to Regulation (EC) No 1272/2008.
- Executive summary:
The testing of the substance on skin irritation/corrosion was performed in six New Zealand White rabbits according to OECD guideline 404. In two treatment groups (4 hours or 3 minutes exposure) with three animals respectively 500 mg of the test item were applied to the skin under semiocclusive conditions.
Treatment 4 hours30 - 60 minutes up to 7 days after removal of the plaster the animals showed very slight up to well-defined erythema. 24 up to 48 hours after removal of the plaster very slight oedema was observed in one animal. Additionally, the skin surface of one animal was parchment-like, dry-rough, fine scaled and small discolored beige. 7 days after removal of the plaster a scar was noted in one animal.
Treatment 3 minutes
30 - 60 minutes up to 7 days after removal of the plaster two animals showed very slight up to moderate erythema and very slight oedema. Additionally, the skin surface was dry-rough and fine scaled. Additionally, the skin surface of one animal was encrusted, indurated and small discolored brown. 14 days after removal of the plaster a scar was noted in one animal.
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