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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 1991-08-06 to 1991-08-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP study in accordance with recognised test guideline but: Lot/batch No.: not stated Expiration date of the lot/batch: not stated NOTE: study deemed acceptable because spectral data for test item are available, covering approximately before and after the test period - see section 1.4 Analytical Information.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Purity: Ca. 100%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, England
- Age at study initiation: 3 months
- Weight at study initiation: 2.72 - 2.89 kg
- Housing: They were housed in suspended stainless steel cages (Type RC10/L) mounted in mobile batteries (Modular Systems and Development Company Limited, London, England). The cages measured 61 x 76 x 46 cm high and were fitted with perforated counter-sunk floor panels.
- Diet (e.g. ad libitum): ad libitum, S. Q. C. Rabbit Diet, Special Diet Services Limited, Witham, Essex, England
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 23 Target 18
- Humidity (%): Range 40 - 70 Target 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 6 August 1991 To: 9 August 1991

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5g
Duration of treatment / exposure:
4 hour
Observation period:
72 hours
Number of animals:
Three male rabbits
Details on study design:
TEST SITE
- Area of exposure: 3 x 2 cm
- % coverage: 100
- Type of wrap if used: an unmedicated gauze patch (3 x 2 cm) which was held in place on the left test site by strips of Blenderm (3-M Company). The right test site, acting as a control, was covered by a similar semi-occlusive dressing but otherwise remained untreated. Pads of cotton wool and elasticated bandage were used to protect the patches and ensure good contact between the skin and the test material during the four-hour exposure period. The elasticated bandage was held in place by thin strips of waterproof plaster ('Sleek' - T &J Smith and Nephew Limited) at both edges.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, the treatment sites were then gently washed with warm water and dried with paper towels to remove excess test material adhering to the skin.
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize

Actual criteria for assessment of skin irritation responses are given in Attached Background Information.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
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:
Of the three rabbits used under test, none of them showed any response at any time.
Other effects:
No dermal response was observed at the test site of any animal at any time during the 72 hour observation period.
The control sites did not show any response to the control procedure. The mean values for erythema and oedema recorded 24, 48 and 72 hours after treatment did not equal or exceed the EEe limit values considered to indicate a significant inflammatory response to treatment.

Any other information on results incl. tables

Scoring of irritance responses:

Animal Number

Type
of Response

Score after removal of dressings

1 hour

24 hour

48 hour

72 hours

Test site

Control
site

Test site

Control
site

Test site

Control
site

Test site

Control
site

91 1437M

Erythema

0

0

0

0

0

0

0

0

Oedema

0

0

0

0

0

0

0

0

91 1439M

Erythema

0

0

0

0

0

0

0

0

Oedema

0

0

0

0

0

0

0

0

91 1441M

Erythema

0

0

0

0

0

0

0

0

Oedema

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Under the conditions of this test, the test item was classified as 'non-irritant' to the skin.
Executive summary:

The potential of test item to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 g of the test material to the closely-clipped dorsa of three New Zealand White rabbits for four hours according to OECD 404. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings.

No dermal response was observed at the test site of any animal at any time during the 72 hour observation period.

Under the conditions of this test, the test item was classified as 'non-irritant' to the skin.