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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:
December 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Information on substance identity and composition is lacking. Batch No. is given, guideline 404 is followed and study is performed according to GLP. Statement from company owner is received on substance identity and composition mentioned in study report. Based on this the reliability turned into 2. If substance identity and composition was reported in study report then reliability would turn into 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
- Age of animals is not mentioned.
GLP compliance:
yes

Test material

Constituent 1
Test material form:
liquid
Details on test material:
- physical state: colourless liquid
date of receipt: 14.11.95
storage conditions: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, France
- Age at study initiation: no info
- Weight at study initiation: on the day of treatment 2.5 ± 0.3 kg
- Housing: Individual housing
- Diet (e.g. ad libitum): free access to pelleted diet
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12h/12h


IN-LIFE DATES: From: December 12, 1995 To: December 17, 1995

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 per animal
- Concentration (if solution): test material was used in its original form


VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
- Initial test in 1 animal: one flank 3 minutes; other flank 4 hours
- Confirmatory test in 2 animals: 4 hours
Observation period:
- 3 days (approximately 1, 24, 48 and 72 hours after patch removal)
- when there is persistent cutaneous irritation after 72 hours the observation period is extended to a maximum of 14 days (until day 15)
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: A single dose of 0.5 ml of the test material was applied to a 6 cm2 gauze pad, which was then applied to the right flank (4 hours in all animals) or the left flank (3 minutes in 1 animal) of the animals. The untreated skin served as control.
- % coverage: no info
- Type of wrap if used: The test material and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and restraining bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No residual test substance was noted at removal of the dressing.
- Time after start of exposure: not applicable


SCORING SYSTEM: see below

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation or corrosion mentioned.
Other effects:
No.

Any other information on results incl. tables

Summary of dermal lesions on clipped and intact skin (following 4-h application).

Remark: No cutaneous reactions were observed after an application of three minutes during the initial test in one animal.

no.

Effect

Hour

Days after application

Mean score erythema

24/48/72 h

Mean score oedema

24/48/72 h

1

1

2

3

7

14

 

 

 

01

Erythema/ eschar

Oedema

0

 

0

0

 

0

0

 

0

0

 

0

-

 

-

-

 

-

 

0

 

 

 

 

0

02

Erythema/ eschar

Oedema

0

 

0

0

 

0

0

 

0

0

 

0

-

 

-

-

 

-

 

0

 

 

0

03

Erythema/ eschar

Oedema

1

 

0

0

 

0

0

 

0

0

 

0

-

 

-

-

 

-

 

0

 

 

0

Mean Group

 

 

 

 

 

 

 

 

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

 In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of Aqualenc F was applied on the clipped skin of 3 males New Zealand White rabbits.

An initial test was performed in one animal with exposure periods of 3 minutes and 4 hours. No cutaneous reactions were observed after an application of 3 minutes. A confirmatory is performed in two other animals.

The single 4-hour, semi-occluded application of the test material to the intact skin of all three animals produced immediately after patch removal very slight erythema at the test site of one animal. This effect was gone at 24 hours after patch removal. Necrosis and ulceration were not reported.

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

Under the test conditions, test substance is not classified according to the Annex VI of Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

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