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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:
weight of evidence
Study period:
From October 29 to December 08, 1979
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Pre-GLP and pre-guideline study. Deviations from OECD test guideline No 404: no recovery period although irritation still present at the 72-h observation time, draize scale not used.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no recovery period although irritation still present at the 72-h observation time, draize scale not used, no details on housing of animals and environmental conditions of animal room; body weights not recorded
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: Clear, colorless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9-12 weeks

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
24, 48 and 72 h after treatment
Number of animals:
7
Details on study design:
TEST SITE
- Area of exposure: Dorsal area
- % coverage: No data
- Type of wrap if used: Occlusive patches prepared by heat-sealing 1ʺ x 1ʺ 24 ply gauze pads on to 1.25ʺ x 1.25ʺ squares of polythene sheeting which is then attached to 3.5ʺ x 1ʺ strips of adhesive tape were used.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treatment sites were wiped clean of excess test material.
- Time after start of exposure: 4 h

SCORING SYSTEM: Using 8-point anchored ordinate scale ranging from "a" (very slight) to "h" (severe).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
other: total score of 7 animals
Time point:
24/48/72 h
Score:
164
Reversibility:
not reversible
Remarks on result:
other: mean score/site: 23.43; mean score/site/day: 5.86
Irritation parameter:
erythema score
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritant / corrosive response data:
- Very slight to quite distinct erythema and very slight to well-developed oedema were observed.
- Very slight to slight cracking was observed in 2/7 and 5/7 animals at 48 and 72 h, respectively.
- Very slight to slight scaling was observed in 2/7 and 3/7 animals at 48 and 72 h, respectively.
- Diffuse ‘pin-prick’ spots of haemorrhage were observed in 3/7 animals at 4 h.
- Very slight to slight pale brown discoloration of skin over 1/4 of test site was observed in one animal at 24 and 48 h.
- Test material produced a variable reaction from marginal to distinct with suspected necrosis in one animal and haemorrhaged areas in two animals after 72 h.
Other effects:
None

Any other information on results incl. tables

Tentative conversion to Draize scale:

Reaction grade a & b <=> Score 1

Reactions grade c & d <=> Score 2

Reactions grade e & f <=> Score 3

Reactions grade g & h <=> Score 4

Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test (intact skin)

 

Score at time point / Reversibility

Erythema

Max. score 4

Oedema

Max. score 4

4 h

1 / 2 / 2 / 2 / 1 / 2 / 0

1 / 2 / 2 / 2 / 0 / 2 / 0

24 h

2 / 2 / 2 / 2 / 1 / 2 / 1

3 / 3 / 2 / 3 /0 / 3 / 0

48 h

2 / 2ab / 2 / 2 / 1 / 2 / 1ab

2 / 3 / 3 / 3 / 0 / 2 / 0

72 h

2ab / 2ab / 2a / 2 / 1 / 1a / 0ab

1 / 2 / 2 / 2 / 0 / 1 / 0

Average 24h, 48, 72h

2 / 2 / 2 / 2 / 1 / 1.67 / 0.67

2 / 2.67 / 2.33 / 2.67 / 0 / 2 / 0

Reversibility*)

nc.

nc.

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

a) Cracking

b) Scaling

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the test condition, test material is classified as irritant to the rabbit skin (Category 2) according to Regulation (EC) No.1272/2008 (CLP) and to the GHS.
Executive summary:

In a dermal irritation study, 0.5 mL of undiluted test material was dermally applied on the clipped dorsum of 10 New Zealand White rabbits for 4 h under semi-occlusive dressing. Skin irritation was assessed and scored at 24, 48 and 72 h after the removal of the patch.

Very slight to quite distinct erythema and very slight to well-developed oedema were observed. Very slight to slight cracking was observed in 2/7 and 5/7 animals at 48 and 72 h, respectively. Very slight to slight scaling was observed in 2/7 and 3/7 animals at 48 and 72 h, respectively. Diffuse ‘pin-prick’ spots of haemorrhage were observed in 3/7 animals at 4 h. Very slight to slight pale brown discoloration of skin over 1/4 of test site was observed in one animal at 24 and 48 h. Test material produced a variable reaction from marginal to distinct with suspected necrosis in one animal and haemorrhaged areas in two animals after 72 h.

Under the test condition, test material is classified as irritant to the rabbit skin (Category 2) according to Regulation (EC) No.1272/2008 (CLP) and to the GHS.