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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:
14 Oct. - 07 Nov. 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
JUSTIFICATION FOR PERFORMING AN IN VIVO STUDY: The in vitro study report (Harlan 2014) concluded the test item to be corrosive to skin. However, this result is related to the specific physico-chemical properties (aprotic polar solvent forming multiphasic systems with water) of the test substance and false positive results in in vitro tests are expected. Therefore, the result is considered to be borderline (inconclusive) and it was recommended to perform an in vivo study to obtain a reliable classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 24 April 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
MHRA, UK GLP Monitoring Authority

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cyrene™- Analytical purity: 99%- Expiration date of the lot/batch: 30-Sep-2015- Storage condition of test material: At 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 Ltd., Leicestershire, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.55 or 2.74 kg
- Housing: individually housed in suspended cages
- Diet: 2930C Teklad Global Rabbit diet, Harlan Laboratories UK Ltd., Oxon, UK ; ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): at least fifteen changes
- Photoperiod (hrs dark / hrs light): 12/12The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied: 0.5 mL- Concentration: 100%
Duration of treatment / exposure:
Initial test: 3 min, 1 h and 4 h
Confirmatory test: 4 h
Observation period:
72 hours. Reading time points: 1, 24, 48 and 72 h
Number of animals:
2, male
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The cotton gauze patch, to which the test substance was applied, was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test item was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: One patch was removed at each of three time points.
SCORING SYSTEMDraize classification scheme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
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
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema 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 #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No evidence of skin irritation was observed during this study. At all reading time points all scores were "0". No corrosive effects were noted.
Other effects:
- Other adverse local effects: No evidence of skin irritation was noted in any test animal folllowing 3-minute, 1-hour or 4-hour application.
- Other adverse systemic effects: No adverse changes in body weight gain.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a skin irritation study, conducted according to OECD 404 Test Guideline and in compliance with GLP, the test material was concluded to be not irritating to skin.