2-chlorotoluene

Endpoint summary

Description of key information

In a study according to OECD testguideline 406 (guinea pig maximisation test according to Magnusson and Kligman) no sensitising potential of the test substance was found.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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

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.

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

Route:

intradermal and epicutaneous

Vehicle:

other: Cremophor E1 in physiological saline

Concentration / amount:

intradermal induction: 5 %
topical induction: 100 %

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

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.

No animal died during the course of the experiment.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

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.

This results is supported by two non-reliable (RL4, cited from secondary source) studies.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

There are no data on respiratory sensitization available

Justification for classification or non-classification

In a guinea pig maximisation test (according to Magnusson and Kligman)  2-chlorotoluene was not sensitising. A classification according to EU Regulation 1272/2008 (CLP) is therefore not warranted.