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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:
18 February 2009 to 21 February 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

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)
Remarks:
Date of inspection: 19 August 2008; Date of signature: 04 March 2009

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification : H-CB sodium salt
Description : blue solid
Lot number : MB-2
Date received : 04 December 2008
Storage conditions : room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Harlan Laboratories UK Limited, Bicestor, Oxon, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.75 to 2.96 kg
- Housing: Individually housed in suspended cages.
- Diet: Free access to food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study.
- Water: Free access to mains drinking water was allowed throughout the study.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Twelve hours of continuous light (06:00 to 18:00) and twelve hours of darkness.

IN-LIFE DATES: From: Day 0 To: termination

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
Moistened with distilled water.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 ml distilled water.

Duration of treatment / exposure:
Four hours.
Observation period:
1, 24, 48 and 72 hours after removal of patches.
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm patches applied to the dorsal/flank
- Type of wrap if used: cotton gauze patch secured in position with a strip of surgical adhesive tape followed by an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, Austin, Texas, p. 46 - 59.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
68264: male
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed.
Remarks on result:
other: Blue coloured staining of the skin.
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
68265: male
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed.
Remarks on result:
other: Blue coloured staining of the skin.
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
68264: male
Time point:
other: mean of 24, 48 snd 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed.
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
68265: male
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed.

Any other information on results incl. tables

Skin Reactions

Blue coloured-staining was noted at the treatment sites of both animals throughout the study. No evidence of skin irritation was noted during the study.

Bodyweight

All animals showed expected gain in bodyweight during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a primary irritation index of 0.0. No corrosive effects were noted.

The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Dirctive 2001/59/EC.
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 Regulation (EC) No. 440/2008

Results. A single 4 -hour, semi-occluded application of the test material to the intact skin of two 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 classification as irritant pr corrosive according to the EU labelling regulations Commission Directive 2001/59/EC.