Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 July 1992 - 17 July 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study report is of good quality and the study was conducted to GLP and documented test parameters are based on specific national guidelines, the purity of test substance is not reported and actual test guideline references are not quoted in test report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
The study report states that the methodology used met OECD and EEC guidelines.
GLP compliance:
yes
Remarks:
The study report contains a statement of Quality Assurance, and a statement of GLP compliance, but no formal GLP certificate issued by a competent authority or other official body was provided.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MMB-Ac
- Physical state: Liquid
- Lot/batch No.: 32840
- Storage condition of test material: Stored in the dark, under ambient conditions.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Limited, Abbots Ripton Road, Wyton, Huntingdon, Cambs, PE17 2DT.
- Weight at study initiation: 3.2-3.5kg
- Housing: Individually in aluminium cages with grid floors beneath which were absorbent paper lined trays
- Diet (e.g. ad libitum): ad libitum Standard Rabbit Diet, supplied by Special Diets Services Limited, 1 Stepfield, Witham, Essex, CM8 3AD,
- Water (e.g. ad libitum): ad libitum tap water
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): mean 47
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5ml
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 h after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- 6cm2 of skin
- Type of wrap if used: Gauze patch, held in place by micropore tape, bound with elastoplast elastic bandage

REMOVAL OF TEST SUBSTANCE
- Skin wiped with water dampened tissue to remove surplus test material
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 - 24 Hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 Hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0 - 72 Hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable as no edema seen.
Irritant / corrosive response data:
Very slight erythema (score 1) was noted at all test sites at the 1h and 24 h assessments. Full recovery was noted 48 h after patch removal. No oedematous responses were noted at any time during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Although the study concluded that the test material was slightly irritating, when assessed according to Directive 67/548/EEC, the results do not indicate classification as irritating. Criteria used for interpretation of results: EU
Conclusions:
MMB-Ac is slightly irritant to rabbit skin.
Executive summary:

The acute dermal irritation potential of a test material, MMB-Ac, was investigated in 3 New Zealand White rabbits.

Very slight erythema (score I) was noted at all test sites at the 1 h and 24 h assessments, with full recovery noted at 4B h after patch

removal. MMB-Ac is slightly irritant to rabbit skin.