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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
27.10.1986 - 05.12.1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-compliant study performed according to internationally accepted testing guideline OECD 406.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
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

Test material

Constituent 1
Chemical structure
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

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:
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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