Registration Dossier
Registration Dossier
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EC number: 203-242-7 | CAS number: 104-83-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1986-10-27 to 1986-12-05
- 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 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- : Number of animals
- Principles of method if other than guideline:
- Number of tested animals: 10
Number of animals in control group: 5 - GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Non-LLNA method results available from pre-LLNA time
Test material
- Reference substance name:
- α,4-dichlorotoluene
- EC Number:
- 203-242-7
- EC Name:
- α,4-dichlorotoluene
- Cas Number:
- 104-83-6
- Molecular formula:
- C7H6Cl2
- IUPAC Name:
- 1-chloro-4-(chloromethyl)benzene
- Details on test material:
- p-Chlorobenzyl chloride D
State of matter: solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright -White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Guinea pig, strain: Pirbright-White
- Source: Hoechst AG, Kastengrund, SPF-Zucht
- Weight at study initiation: 317 g
- 15 ( female)
ENVIRONMENTAL CONDITIONS
- Diet: ERKA-Mischfutter Nr. 8300 für Meerschweinchen und Kaninchen (ad libitum)
- Water: tap water (ad libitum)
- Temperature: 22 °C +/- 3 °C
- Humidity: 50 % +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 / 12
- Acclimation: > 5 days
- Housing: 4 animal per cage
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: induction: paraffin oil; challenge: vaseline
- Concentration / amount:
- 1 % test substance for intradermal and epicutaneous treatment
Challenge
- Concentration / amount:
- 1 % test substance for intradermal and epicutaneous treatment
- No. of animals per dose:
- 10 (dose group)
5 (control groups and satellite group) - Details on study design:
- RANGE FINDING TESTS:
Estimation of the concentration for epicutaneous induction and challenge treatment:
Epicutaneous application of p-chlorobenzyl chloride at concentrations of 10%, 1%, and 0.1% in vaseline (6 animals).
Dermal treatment with 10 % test item caused barley perceptible erythema and slight edema. 1 % and 0.1 % did not cause any skin reactions.
Estimation of the concentration for intradermal induction exposure:
Injection of p-chlorobenzyl chloride at concentrations of 5%, 1%, and 0.2% in paraffin oil (3 animals).
Intradermal injection of 0.2 % test item caused slight erythema and edema. 1 % and 5 % caused more severe erythema and edema. 5 % caused also hardening of the skin.
Satellite group:
Dermal treatment with 1 % test item of the animals pre-treated with Freud's adjuvans did not result in skin reactions.
Based on these results, 1 % was selected as concentration for intradermal and dermal treatemtent.
MAIN STUDY
A1. INDUCTION EXPOSURE (intradermal)
- Test group: Position 1: 2 x 0.1 mL 50 % Freunds Complete Adjuvant (FCA); Position 2: 2 x 0.1 mL 1 % in paraffin oil; Position 3: 2 x 0.1 mL 1 % in FCA
- Control group: Position 1: 2 x 0.1 mL 50 % Freunds Complete Adjuvant (FCA); Position 2: 2 x 0.1 mL paraffin oil; Position 3: 2 x 0.1 mL 50 % FCA
- Satellite group: Position 1: 2 x 0.1 mL 50 % Freunds Complete Adjuvant (FCA); Position 2: 2 x 0.1 mL paraffin oil; Position 3: 2 x 0.1 mL 50 % FCA
- Site: upper ridge (near shoulder region)
- Frequency of applications: 1
- Concentrations: 1%
A2. INDUCTION EXPOSURE (dermal)
- No. of exposures: 1
- Exposure period: 48 h
- Test group: 1% in vaseline
- Control group: vaseline
- Satellite group: vaseline
- Site: intradermal exposure sites
- Concentrations: 1%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 22 (test group/control group), 15 (satellite group)
- Exposure period: 24 h
- Test group: 1% in vaseline
- Control group: 1% in vaseline
- Satellite group: 1% in vaseline
- Site: left flank
- Concentrations: 1%
- Evaluation (hr after challenge): 48 h, 72 h - Challenge controls:
- see above
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0 % p-Chlorobenzyl chloride
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Erythema: score 3 (mean); oedema: score 1.8 (mean, 6/10); scab: 8/10 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0 % p-Chlorobenzyl chloride. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Erythema: score 3 (mean); oedema: score 1.8 (mean, 6/10); scab: 8/10 animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1.0 % p-Chlorobenzyl chloride
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Erythema: score 3.1 (mean); oedema: score 2 (mean, 3/10); scab: 7/10 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1.0 % p-Chlorobenzyl chloride. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Erythema: score 3.1 (mean); oedema: score 2 (mean, 3/10); scab: 7/10 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1.0 % p-Chlorobenzyl chloride
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Erythema and oedema: Score 0 (mean)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1.0 % p-Chlorobenzyl chloride. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Erythema and oedema: Score 0 (mean).
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1.0 % p-Chlorobenzyl chloride
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Erythema and oedema: Score 0 (mean)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1.0 % p-Chlorobenzyl chloride. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Erythema and oedema: Score 0 (mean).
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: satellite
- Dose level:
- 1.0 % p-Chlorobenzyl chloride
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Erythema and oedema: Score 0 (mean)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: satellite. Dose level: 1.0 % p-Chlorobenzyl chloride. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Erythema and oedema: Score 0 (mean).
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- other: satellite
- Dose level:
- 1.0 % p-Chlorobenzyl chloride
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Erythema and oedema: Score 0 (mean)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: other: satellite. Dose level: 1.0 % p-Chlorobenzyl chloride. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Erythema and oedema: Score 0 (mean).
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: no positive control group
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Executive summary:
In a guinea pig maximisation test p-chlorobenzyl chloride was tested at a challenge concentration of 1% in vaseline. The animals were induced with 1 % test item in paraffin oil and vaseline for intradermal and dermal induction, respectively. No signs of systemic toxicity were observed in the dose group during the study. All test group animals showed signs of sensitisation following challenge treatment. In the control group and satellite group, no local effects were registered after the challenge. In this study it was demonstrated that p-chlorobenzyl chloride is a dermal sensitizer.
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