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Registration Dossier
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EC number: 210-258-8 | CAS number: 611-19-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27.10.1986 - 05.12.1986
- Reliability:
- 2 (reliable with restrictions)
- 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:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test performed before LLNA was standard
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:
- - Name of test material: p-Chlorobenzyl chloride D
- Physical state: solid
- Analytical purity: > 99%
- Composition of test material, percentage of components:
ca. 99.5% p-Chlorobenzyl chloride
ca. 0.3% m-/p-Chlorobenzal chloride
ca. 0.2% other
- Purity test date: 02.09.1986
- Lot/batch No.: GLAA 405
- Storage condition of test material: in the dark at 22°C, extractor hood
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, SPF breeding
- Age at study initiation: not indicated
- Weight at study initiation: 235 - 362 g (mean: 317 g)
- Housing: Macrolon cage type 4, 5 animals per group
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: min 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12
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 epccutaneous treatment
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: induction: paraffin oil; challenge: vaseline
- Concentration / amount:
- 1 % test substance for intradermal and epccutaneous 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 chellenge treatment:
Epicutaneous application of p-Chlorophenyl chloride at concentrations of 10%, 1%, and 0.1% in vaseline (6 animals)
Estimation of the concentration for intradermal induction exposure:
Injection of p-Chlorophenyl chloride at concentrations of 5%, 1%, and 0.2% in paraffin oil (3 animals)
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
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Group:
- positive control
- Dose level:
- none
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- none
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- 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).
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 chellenge concentration of 1% in vaseline. The animals were induced with 1 % test item in paraffin oil and vaseline for intradermal and dermal induction, repsectively. 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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