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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report: T-7479
- Physical state: Clear colorless liquid
- Analytical purity: Assumed to be 100%
- Expiration date of the lot/batch: 23 March 2002
- Storage condition of test material: At room temperature and in the dark.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: approximately 3 weeks old
- Weight at study initiation: < 500 g
- Housing:

Group housing of 5 animals per labelled metal cage (57 cm x 41 cm x 23 cm height) with wire-mesh floors. The acclimatisation period was at least 5 days before the start of treatment under laboratory conditions.


- Diet (e.g. ad libitum): ad libitum, standard guinea pig diet, including ascorbic acid (1000 mg/kg)
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/1 3 deg C.
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12/

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
neat
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
neat
No. of animals per dose:
10 controls, 20 treated at 100%
Details on study design:
MAIN STUDY

A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: 6 hours
- Test groups: 20 females
- Control group: 10 females
- Site: left side of scapular region
- Frequency of applications: Days 1, 8 and 15
- Concentrations: Neat

B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 29
- Exposure period: 6 hours
- Test groups: one (20 females)
- Control group: (10 females)
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
Same as treated animals
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
SEE TEXT in Section Overall Remarks (too less characters in this field)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: SEE TEXT in Section Overall Remarks (too less characters in this field).

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There was no evidence that the test stubstancehad caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase.
This result indicates a sensitisation rate of 0 per cent.
Executive summary:

The Buehler type of sensitisation was conducted based on the results of the Preliminary Irritation Test (NOTOX project 313324) and trial formulations peformed at NOTOX. The test substance formed an inhomogenous formulation in the vehicle tested, and injection with the undiluted test substance resulted in necrosis. Therefore, in consultation with the sponsor, the undiluted test substance was used for the Buehler Test which is the preferred test after the Guinea Pig Maximization Test.

In the Main study, twenty experimental animals were epidermally treated on three occasions (days 1, 8 and 15) with the undiluted test substance and ten control animals were similarly treated, but with vehicle alone (water). Two weeks after the last induction exposure, all animals were challenged with the undiluted test substance and the vehicle.

No skin reactions were evident after the challenge exposure in the experimental and control animals.

There was no evidence that the test substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase.