Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was performed between 29 March 2007 and 01 April 2007.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification: C-Y9
Description : yellow powder
Batch number : MB-1
Date received : 06 March 2007
Storage conditions: room temperature in the dark over silica gel

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Three New Zealand White rabbits were supplied by an accredited supplier.
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation: 2.0 to 3.5 kg.
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to food (Certified Rabbit Diet) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): The lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Test material moistened with distilled water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A quantity of 0.5 g of the test material, moistened with 0.5 ml of distilled water, was introduced.


Duration of treatment / exposure:
4 h
Observation period:
72 hours.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure:
A quantity of 0.5 g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin.
- Type of wrap if used:
The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

SCORING SYSTEM:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale (see any other information on materials and methods).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
: Animal 1
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
: Animal 2
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
: Animal 3
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
: Animal 1
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
: Animal 2
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
: Animal 3
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
The individual scores for erythema/eschar and oedema are given in Table 1.
No evidence of skin irritation was noted during the study.
Other effects:
Yellow-coloured staining was noted at all treated skin sites throughout the study. This did not affect evaluation of skin reactions.

Any other information on results incl. tables

Table1               IndividualSkin Reactions

Skin Reaction

Observation Time

Individual Scores – Rabbit Number and Sex

Total

66076 Male

66077 Male

66078 Male

Erythema/Eschar Formation

1 Hour

0STA

0 STA

0 STA

(0 )

24 Hours

0 STA

0 STA

0 STA

0

48 Hours

0 STA

0 STA

0 STA

( 0 )

72 Hours

0 STA

0 STA

0 STA

0

Oedema Formation

1 Hour

0

0

0

( 0 )

24 Hours

0

0

0

0

48 Hours

0

0

0

( 0 )

72 Hours

0

0

0

0

Sum of 24 and 72-hour Readings (S):              0

Primary Irritation Index (S/6)                             :              0/6 = 0.0

Classification                                                       :              NON-IRRITANT


STA= Yellow-coloured staining

(   ) = Total values not used for calculation of primary irritation index

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a primary irritation index of 0.0 and was classified as NON IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material did not meet the criteria for classifcation as a skin irritant according to EU CLP regulations.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC (Dangerous Substances Directive).

Executive summary:

Introduction. 

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

§        OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted)

§        Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC

Results. 

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation.

Conclusion. 

The test material produced a primary irritation index of 0.0 and was classified as non‑irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material did not meet the criteria for classifcation as a skin irritant according to EU CLP regulations.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC (Dangerous Substances Directive).