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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 October 1985 to 1 November 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: by Nottingham UnÍversity, School of Agriculture, Sutton BonÍngton, Leicestershire, U.K
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.36-3.36 kg
- Housing: individually
- Diet: Rabbit Diet, A.l.l. Tindall Limited, Holbeach, Lincolnshire UK ad libitum
- Water:. ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 °C
- Humidity (%): 45-58%
- Air changes (per hr): ca 15/hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch wrapped with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with water moistened cotton wool and thereafter with ether
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS: at 1 hour 24, 48 and 72 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
no irritant effects
Other effects:
faint yellow staining of the skin was observed, that did not prevent erythema scoring

Any other information on results incl. tables

Animal 1 2 3
1 24 48 72 1 24 48 72 24 48 72
erythema 0 0 0 0 1 1 0 0 0 0 0 0
oedema 0 0 0 0 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritant to the skin
Executive summary:

In a test according to OECD 404 3 rabbits were exposed dermally to the substance under semi-occlusion for 4 hours. No signs of irritation were observed at the 1, 24, 48 and 48 hour observations. A slight yellow staining of the skin was seen. The substance is not irritant to the skin.