Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Analogue substance tested; GLP study using standard method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: 92/69/EEC, B4
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:D. Percival, Mosto Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2,53 -2,88 kg
- Housing:individual
- Diet (e.g. ad libitum): ad- lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: >5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 C
- Humidity (%): 49-69
- Air changes (per hr) : 15
- Photoperiod (hrs dark / hrs light): 12 /12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
Substance applied as supplied moistened with distilled water
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
3 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6,25 cm²
- Type of wrap if used: cotton gauze + surgical adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4h

SCORING SYSTEM: Draize scale (Draize J.H. "Dermal and eye toxicity tests" In: Principles and procedures for evaluating the toxicity of household substances, National academy of sciences, Washington D.C.; USA 1977, p. 31)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Other effects:
no

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
An analogue substance did not produce significant irritation responses in rabbits, Thus, the substanceis not expected to cause skin irritation.