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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:
From 1994-04-26 to 1994-04-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study performed according to OECD test guideline No. 404 and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
yes
Remarks:
no data on the age of animals at study initiation
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no data on the age of animals at study initiation
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
UK GLP Compliance Program (Inspection date: 1992-10-27)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: clear colourless liquid
- Storage condition of test material: in the dark at approximately 4°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield Farms (UK) Limited, Froxfield, Hamshire.
- Age at study initiation: no data
- Weight at study initiation: 3.5, 3.7 and 3.9 kg
- Housing: individually in grid bottomed metal cages.
- Diet (e.g. ad libitum): antibiotic free rabbit diet ad libitum (SQC standard rabbits pellets, produced by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21 °C.
- Humidity (%): 43-73 % with the exception of one occasion when the recorded relative humidity exceeded the protocol specific upper limit. This deviation is considered not to have affected the outcome of the study.
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, and 72 hours after patch removal
Number of animals:
3 females
Details on study design:
Initially, one animal was dosed in a preliminary screen to estimate the potential irritancy of the test article. Twenty four hours after patch removal a further 2 animals were dosed.

TEST SITE
- Area of exposure: dorsal surface of the trunk
- % coverage: 2.5 cm square
- Type of wrap if used: surgical lint held in position with "Elastoplast" elastic adhesive bandage 7.5 cm wide.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale (according to OECD guideline No. 404)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
One hour after patch removal, a well-defined erythema was noted at the treated sites on 2 animals. This response was accompanied by a barely perceptible oedema in one animal. Very slight oedema was also apparent in the third rabbit at this time.
At the 24 hour observation, the treated skin site on all 3 animals was free of signs of irritation and remained so at the 48 and 72 hour examination.
Other effects:
None

Any other information on results incl. tables

Table 7.3.1/1: Irritant/corrosive response data for 3 animals at each observation time up to removal of animals from the test

 

Score at time point / Reversibility

Erythema

Max. score 4

Oedema

Max. score 4

1 h

0.0 / 2.0 / 2.0

1.0 / 0.0 / 1.0

24 h

0.0 / 0.0 / 0.0

0.0 / 0.0 / 0.0

48 h

0.0 / 0.0 / 0.0

0.0 / 0.0 / 0.0

72 h

0.0 / 0.0 / 0.0

0.0 / 0.0 / 0.0

Average 24h, 48h, 72h

0.0 / 0.0 / 0.0

0.0 / 0.0 / 0.0

Reversibility*)

-

-

Average time (day) for reversion**

-

-

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

**): correspond to the last day for which skin irritation signs in the last animal were observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the mean scores calculated within 3 scoring times (24, 48 and 72 hours) for each animal were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema.
Executive summary:

In a dermal irritation study performed similarly to the OECD guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted ST 06 C 93 was dermally applied on the shaved skin of the dorsal surface of the trunk of 3 females New Zealand White rabbits.Test sites were covered with a semi-occlusive dressing for 4 hours.

Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 h after the removal of the patch.

The mean scores calculated within 3 scoring times (24, 48 and 72 hours) for each animal were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema.

One hour after patch removal, a well-defined erythema was noted at the treated sites on 2 animals. This response was accompanied by a barely perceptible oedema in one animal. Very slight oedema was also apparent in the third rabbit at this time. No signs of irritation were observed at 24, 48 and 72 hours.

 

Therefore, ST 06 C 93 does not require a classification as irritant to the skin according to the the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.