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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 1992-08-24 to 1992-09-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study conducted according to the original OECD Guideline 404 (1981).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(Adopted 12th May 1981)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): 8α,-11-Oxido-13,14,15,16-tetranorlabdan / Ambroxan
- Physical state: white solid
- Stability under test conditions: stable for at least 2 years
- Storage condition of test material: cool and dark

Test animals

Species:
rabbit
Strain:
other: Kleinrussen, Chbb:HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Thomae GmbH, Biberach-D
- Age at study initiation: approximately 19 months
- Weight at study initiation: approximately 2460 g
- Housing: individual accommodation
- Diet (e.g. ad libitum): Ssniff rabbit diet K4, Ssniff GmbH, Soest-D (Batch 550792/01) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 20-25°C
- Humidity (%): approximately 45-70%
- Air changes (per hr): at least eight per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: August 24, 1992 To: September 07, 1992

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
moistened
Controls:
other: untreated skin areas serve as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours and 7 days after exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: right flank
- % coverage: ca. 6 cm²
- Type of wrap if used: adhesive air- and vapour permeable gauze-patch fixed by a hypo-allergenic adhesive gauze-bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, but no detail
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale, as described in OECD Guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #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
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Scratching was observed at 24-48-72 hours
Irritant / corrosive response data:
Slight to weak erythema and slight oedema of the first, slight erythema of the second, and no reaction of the third experimental animals were observed during the first 72 hours after exposure. One week later the first and second experimental animals were without irritation effects.
Other effects:
None

Any other information on results incl. tables

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

 

Score at time point / Reversibility

Erythema

Max. score 4

Oedema

Max. score 4

1 h

1 / 1 / 0

1 / 0 / 0sc

24 h

2 / 1 / 0

1 / 0 / 0sc

48 h

1 / 1 / 0

0 / 0 / 0sc

72 h

1 / 1 / 0

0 / 0 / 0sc

Average 24h, 48h, 72h

1.3 / 1.0 / 0.0

0.3 / 0.0 / 0.0

Reversibility*)

c.

c.

Average time for reversion

7 days

48 hours

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

sc = scratch

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test material induces a slight to weak irritation being reversible within 7 days. Therefore the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
Executive summary:

In a dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, 0.5 g of undiluted test material was moistened and applied on the shaved skin of the dorsal flank area of 3 Kleinrussen, Chbb:HM 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, 72 hours and 7 days after the removal of the patch.

 

Slight to weak erythema and slight oedema of the first, slight erythema of the second, and no reaction of the third experimental animal were observed during the first 72 hours after exposure. One week later the first and the second experimental animal were without irritation effects.

The individual scores for each animal within 3 scoring times (24, 48 and 72 hours) were 1.33 / 1.00 / 0.00 for erythema and 0.33 / 0.00 / 0.00 for oedema.

 

Therefore the test material is not classified as irritant to the skin according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP).

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