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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:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: approx. 50 % w/w aquaous solution of the substance

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 3.03-3.16 kg
- Housing: Individual suspended metal cages
- Diet (e.g. ad libitum): STANRAB SQC Rabbit diet, Special dies Ltd, Witham, Essex, UK, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 44-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 50 % w/w

Duration of treatment / exposure:
3 min, 1 hour, and 4 hours, respectively
Observation period:
14 days after exposure
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 29 Male
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 29 Male
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 29 Male
Time point:
72 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 174 Male
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 174 Male
Time point:
48 h
Score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 174 Male
Time point:
72 h
Score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 175 Female
Time point:
24 h
Score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal: 175 Female
Time point:
48 h
Reversibility:
not reversible
Remarks on result:
other: Adverse reactions prevented accurate evaluation of erythema
Irritation parameter:
erythema score
Basis:
animal: 175 Female
Time point:
72 h
Reversibility:
not reversible
Remarks on result:
other: Adverse reactions prevented accurate evaluation of erythema
Irritation parameter:
edema score
Basis:
animal: 29 Male
Time point:
24 h
Score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 29 Male
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 29 Male
Time point:
72 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 174 Male
Time point:
24 h
Score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 174 Male
Time point:
48 h
Score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 174 Male
Time point:
72 h
Score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 175 Female
Time point:
24 h
Score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 175 Female
Time point:
48 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Adverse reactions prevented accurate evaluation of edema
Irritation parameter:
edema score
Basis:
animal: 175 Female
Time point:
72 h
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: Adverse reactions prevented accurate evaluation of edema
Irritation parameter:
erythema score
Basis:
animal: 29 Male
Time point:
other: 24 hours after 3 min exposure
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 29 Male
Time point:
other: 24 hours after 1 hour exposure
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Discoloration of skin, necrosis and scar tissue was observed during the study.

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
Substance is corrosive to rabbit skin.