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 01 September 2005 and 04 September 2005.
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:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of Inspection: 02/12/2002. Date of signature: 13/02/2003

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification : Barium di(bistridecylsulfosuccinate) in mixture with barium hydrogen phosphate
Description : colourless waxy solid block
Batch number : Y-T-1
Storage conditions: room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Three New Zealand White rabbits were supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: At the start of the study the animals were in the weight range of 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 (Code 5322) supplied by BCM IPS Limited, London, UK) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Acclimation period: At least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was set to achieve limits of 17 to 23°C.
- Humidity (%): The relative humidity was set to achieve limits of 30 to 70% .
Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study.
- Photoperiod (hrs dark / hrs light): The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.


IN-LIFE DATES: From: Day 1 To: Day 3

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test materia, moistened with 0.5 ml of distilled water.
- Concentration (if solution): Not applicable.


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:
4 hours.
Observation period:
72 hours.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: On the day of the test a suitable test site was selected on the back of each rabbit.
- % coverage: Not stated.
- Type of wrap if used: 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. 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
- Washing (if done): Any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: Four hours after application.


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 (please see below - Evaluation of skin reactions):

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
:Animal 93 (male)
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
mean
Remarks:
:Animal 99 (male)
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
: Animal 100 (male)
Time point:
other: Mean of 24, 48 and 72 hours.
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
: Animal 93 (male)
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
: Animal 99 (male)
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
: Animal 100 (male)
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
The individual scores for erythema/eschar and oedema are given in Table 1.
Very slight erythema was noted at all treated skin sites one hour after patch removal and at the 24 hour observation and persisted at two treated skin sites at the 48-hour observation.
Very slight oedema was noted at two treated skin sites at the 24-hour observation.
One treated skin site appeared normal at the 48-hour observation and the remaining two treated skin sites appeared normal at the 72-hour observation.
Other effects:
None.

Any other information on results incl. tables

Table1               Individual Skin Reactions

Skin Reaction

Observation Time

Individual Scores – Rabbit Number and Sex

Total

93 Male

99 Male

100 Male

Erythema/Eschar Formation

1 Hour

1

1

1

(3 )

24 Hours

1

1

1

3

48 Hours

0

1

1

( 2 )

72 Hours

0

0

0

0

Oedema Formation

1 Hour

0

0

0

( 0 )

24 Hours

0

1

1

2

48 Hours

0

0

0

( 0 )

72 Hours

0

0

0

0

Sum of 24 and 72-hour Readings (S):              5

Primary Irritation Index (S/6)                             :              5/6 = 0.8

Classification                                                       :              MILD IRRITANT


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

The test material did not meet the criteria for classification as a skin irritant according to EU classification and labelling regulations (Council Directive 67/548/EEC - Dangerous Substances Directive).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not meet the criteria for classification as a skin irritant according to EU classification and labelling regulations (Council Directive 67/548/EEC - 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 24 April 2002)

§        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 very slight erythema and very slight oedema. One treated skin site appeared normal at the 48-hour observation and the remaining treated skin site appeared normal at the 72‑hour observation.

Conclusion. 

The test material produced a primary irritation index of 0.8 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material did not meet the criteria for classification as a skin irritant according to EU classification and labelling regulations (Council Directive 67/548/EEC - Dangerous Substances Directive).