Registration Dossier
Registration Dossier
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EC number: 202-447-9 | CAS number: 95-75-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzene, 1,2-dichloro-4-methyl-
- IUPAC Name:
- Benzene, 1,2-dichloro-4-methyl-
- Reference substance name:
- 3,4-dichlorotoluene
- EC Number:
- 202-447-9
- EC Name:
- 3,4-dichlorotoluene
- Cas Number:
- 95-75-0
- Molecular formula:
- C7H6Cl2
- IUPAC Name:
- 1,2-dichloro-4-methylbenzene
- Details on test material:
- Content: > 99 %
Colour: colourless
State of matter: liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany
- Average weight at study initiation: 2.1 – 2.5 kg
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 50 +/- 20 %
- Photoperiod: 12 h dark, 12 h light
- Housing: one animal per cage
- Diet: "Altromin 2123" ad libitum and 15 g hay per day
- Water: deionized and chlorinated water (ad libitum)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL 3,4-dichlorotoluene (pur).
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- the skin was shaved 24 h bevore test. Only animals with unimpaired skin were used.
- Area of exposure: 2.5 x 2.5 cm.
- Coverage: plaster with a layer of cellulose, covered with a semioclusive bandage.
After 4 hours of exposure the skin was washed with water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Conclusions:
- 3,4-Dichlorotoluene is classified (67/548/EEC) as non-irritant.
- Executive summary:
In a dermal irritation study (Hoechst AG, 1986) 3 New Zealand White rabbits were dermally exposed to 3,4-dichlorotoluene (pure). The test site (intact, shaved skin) was covered with a plaster with a layer of cellulose for 4 hours. The skin then was washed with water. Rabbits were observed for 14 days. Irritations regarding erythema and edema were scored after 30-60 min, 24 hours, 48 hours, 72 hours, 7 days and 14 days.
The test results lead to a classification according to OECD Guideline 404: non-irritant.
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