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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 03 September 1991 to 27 September 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guiedline study according OECD 406

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
In a guinea pig maximisation test according Magnusson and Kligman 20 male animals (control: 10 male animals) per test group were used.
1. Induction: Intradermal application into the back of 0.1 ml of a 5% solution of p-Chlorotoluene; one week later:
2. Induction: topical application of a plaster containing 0.5 ml undiluted p-chlorotoluene which was fixed by alufole (occlussive condition)
3 weeks after intradermal induction:
Challange with 0.5 ml of undiluted p-chlorotoluene by dermal application, covered with a plaster, for 24 hours.
Afterwards treatment areas were rinsed with physiological saline-solution.
Evaluation: reading was carried out 48 and 72 hours post start of the challenge; evaluation by comparison of the reacting animals between test and control group.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in the year 1991. At this time point no valid and regulatory accepted guideline for a LLNA was available.

Test material

1
Chemical structure
Reference substance name:
2-chlorotoluene
EC Number:
202-424-3
EC Name:
2-chlorotoluene
Cas Number:
95-49-8
Molecular formula:
C7H7Cl
IUPAC Name:
1-chloro-2-methylbenzene
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Bor: DHPW
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, Borchen/Kreis Paderborn, Germany
- Microbiological status of animals, when known: SPF-animals
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: mean: 361 g
- Housing: Makrolon cages Typ IV, 5 animals per cage
- Diet : Altromin 3020, Altromin GmbH Lamge, Germany
- Water: tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2 °C
- Humidity (%): ca. 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: Cremophor E1 in physiological saline
Concentration / amount:
intradermal induction: 5 %
topical induction: 100 %
Challenge
Route:
epicutaneous, semiocclusive
Vehicle:
other: Cremophor E1 in physiological saline
Concentration / amount:
provocation: 100 %
No. of animals per dose:
20
Details on study design:
1st application: Induction 5 % intracutaneous
2nd application: Induction 100 % occlusive epicutaneous
3rd application: Challenge 100 % semiocclusive
Positive control substance(s):
yes
Remarks:
1-chlor-2,4-dinitrobenzol

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no erythema or edema
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no erythema or edema
Remarks on result:
no indication of skin sensitisation
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Cremophor in physiological saline.
Group:
positive control
Remarks on result:
other: 1-chlor-2,4-dinitrobenzol
Remarks:
DIESING, L.: 1-chlor-2,4-dinitrobenzol. Untersuchungen zur Brauchbarkeit des Meerschweinchenstammes DHDP für den Einsatz bei Prüfungen auf hautsensibilisierende Wirkung. BAYER-Bericht Nr. 19316 vom 27.7.1990.

Any other information on results incl. tables

No animal died during the course of the experiment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a study according to OECD testguideline 406 (guinea pig maximisation test according Magnusson and Kligman) o-chlorotoluene was tested in 20 male animals (control: 10 male animals) per test group. None of the animals in the test group (0/20) revealed any signs of erythema or edema at 48 or 72 hours after challenge.
Executive summary:

In a study according to OECD testguideline 406 (guinea pig maximisation test according Magnusson and Kligman) o-chlorotoluene was tested. 20 male animals (control: 10 male animals) per test group were used. The first induction was intradermal (application into the back of 0.1 ml of a 5% solution of o-Chlorotoluene). One week later the second induction was done (topical application of a plaster containing 0.5 ml undiluted o-chlorotoluene which was fixed by alufole (occlussive condition)). Three weeks later the challenge was performed with 0.5 ml of undiluted o-chlorotoluene by dermal application, covered with a plaster, for 24 hours.


Readings were carried out at 48 and 72 hours post start of the challenge. For  evaluation the reacting animals were compared between test and control group. The test was negative, none of the animals in the test group (0/20) revealed any signs of erythema or edema at 48 or 72 hours after challenge.