Registration Dossier
Registration Dossier
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EC number: 210-258-8 | CAS number: 611-19-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23.04.1985 - 07.05.1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- α,2-dichlorotoluene
- EC Number:
- 210-258-8
- EC Name:
- α,2-dichlorotoluene
- Cas Number:
- 611-19-8
- Molecular formula:
- C7H6Cl2
- IUPAC Name:
- 1-chloro-2-(chloromethyl)benzene
- Details on test material:
- Source: HOECHST AG- Code: GLAC 405- Purity: >99%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- 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)
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
- % coverage:
- Type of wrap if used: semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: water
- Time after start of exposure: after incubation period
SCORING SYSTEM:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
No necrosis was observed.
======================================================
Animal Symptom Time after patch removal
No. -----------------------------------
30-60 24 48 72 7 14
min hr hr hr d d
------------------------------------------------------
1 erythema 1 3 3 4 2 0
edema 4 1 1 1 0 0
2 erythema 1 3 3 3 1 0
edema 3 1 1 1 0 0
3 erythema 1 2 2 2 2 0
edema 2 2 1 1 0 0
======================================================
These results have led to the conclusion that OCBC had no
corrosion effect but had a dermal irritation potential on
the rabbit skin under these study conditions.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information R38: Irritating to skin Criteria used for interpretation of results: EU
- Conclusions:
- o-Chlorobenzylchloride exhibited an irritating potential.
- Executive summary:
In a primary dermal irritation study New Zealand White Rabbits were dermally exposed to 0.5 mL of undiluted o-Chlorobenzylchloride (>99 % a.i.). Test sites at the dorsal flank of the back were covered with a semiocclusive dressing for 4 hours. Then application sites were washed with water. Animals were then observed for 14 days. Irritation was scored according to OECD GL 404. 30 - 60 minutes after removal very slight erythema and slight to severe edema were observed. 24 - 72 hours later severe erythema and slight edema were noticed. Dried skin surface was noticed after 48 hours and after 7 days skin surface was chapped. No necrosis was observed. Development of erythema and edema was completely reversible within 14 days. In this study, o-Chlorbenzylchloride exhibited an irritating potential.
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