Registration Dossier

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:
2016-08-23 - 2016-08-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The contract to conduct an in vivo skin irritation study was signed before the entry into force of the amendments (Commission Regulation (EU) 2016/863 from 31 May 2016) to Annexes VII and VIII of the REACH Regulation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

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:
Certificate issued by "The Department of Health and of the Government of the United Kingdom" (2016-10-28).

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Leicestershire, UK
- Age at study initiation: 12 to 52 weeks
- Weight at study initiation: 3.5 or 3.66 kg
- Housing: Individually housed in suspended cages. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose of integrity of the study.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): at least 15 per hr
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
with veterinary clippers
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration: used as provided
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Two females
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: cotton gauze patch secured with surgical adhesive tape. The trunk of each rabbit was wrapped in elasticated corset to prevent the animals interfering with the patches.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test item removed by gentle swabbing with cotton wool soaked in 74% industrial methylated spirits.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later. Test sites were examined for evidence of primary irritation and scored. Any other skin reaction and clinical signs of toxicity, if present, were also recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
Very slight erythema was noted for both treated skin sites at the 24 hour observation. Very slight edema was noted at one treated skin site at the 24 hour observation.
Other effects:
There were no deaths during the study.
Animals showed expected gain in body weight during the study.

Any other information on results incl. tables

Table 1: Individual Skin Reactions.

Skin Reaction Observation Time (following patch removal) Individual Scores Mean 24, 48 and 72 Hour Scores
Rabbit Number and Sex
75517 Female 75518 Female
Erythema/ Eschar Formation Immediately 0 0 0.3
1 Hour 0 0
24 Hours 1 1
48 Hours 0 0
72 Hours 0 0
Edema Formation Immediately 0 0 0.0 and 0.3, respectively
1 Hour 0 0
24 Hours 0 1
48 Hours 0 0
72 Hours 0 0

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS (CLP) criteria not met
Remarks:
not irritating
Conclusions:
The test item produced individual mean scores of 0.3 for erythema (both animals) and 0.0 and 0.3 respectively for edema.
Executive summary:

The in vivo study was performed to assess the irritancy of the test item to the skin of New Zealand White rabbit in accordance with OECD Guideline 404 and EU Method B.4 and in compliance with GLP criteria.

A suitable test site was selected at the back of each rabbit. A quantity of 0.5 mL of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured with a strip of surgical adhesive tape. Residual test item removed by gentle swabbing with cotton wool soaked in 74% industrial methylated spirits after a 4 hour exposure of the test item. Observations were made immediatly following removal of the patches and approximately 1, 24, 48 and 72 hours later. The single 4 -hour, semi occluded application of the test item to the intact skin of two rabbits produced very slight erythema at both treated skin sites at the 24 hour observation. Very slight edema was noted at one treated skin site at the 24 hour observation. Mean scores following grating at 24, 48 and 72 hours following patch removal were calculated for erythema and edema. Calculation of the Primary Irritation Index and Grading of Irritancy Potential Using the Daize Scheme. If irreversible alterations of the dermal tissue is noted in any rabbit, as judged by the Study Director, which include ulceration and clear necrosis or signs of scar tissue, the test item is considered to be corrosive to rabbit skin. Grading according to Draize may, therefore, not be applicable.

The test item produced individual mean scores of 0.3 for erythema (both animals) and 0.0 and 0.3 respectively for edema.