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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 10 to 13, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study performed according to US-FHSA guideline. Deviations from standard method: no data on test animals, 24 h exposure instead of 4h, occlusive dressing instead of semi-occlusive, observation at 24 and 72 h only (no 48h scoring), reversibility not assessed during a 14-day observation period. However, since only minimal responses persisted until the 72-h time point (maximum score = 1), the study results can be used for classification purpose (Ref: CLP Guidance). A new study is unlikely to show worse effects; therefore, this study was considered sufficiently robust to cover this endpoint.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Section 1500.41 - Hazardous Substances and articles, Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973.
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP

Test material

Constituent 1
Reference substance name:
Juniper, Juniperus mexicana, ext., epoxidized
EC Number:
309-066-8
EC Name:
Juniper, Juniperus mexicana, ext., epoxidized
Cas Number:
99811-75-3
Molecular formula:
not applicable (UVCB substance)
IUPAC Name:
(1S,2R,5S,7R)-2,6,6,8-tetramethyltricyclo[5.3.1.0¹,⁵]undecan-9-one; (1aS,2R,4aS,8aS)-2,4a,8,8-tetramethyl-decahydrocyclopropa[e]naphthalen-3-one; (1aS,2S,4aS,8aS)-2,4a,8,8-tetramethyl-decahydrocyclopropa[e]naphthalen-3-one
Test material form:
not specified
Details on test material:
No data

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: one side intact
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g on each site
Duration of treatment / exposure:
24 h
Observation period:
24 and 72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Side of the animal's back
- Type of wrap if used: Treated areas were covered with gauze patches and an impervious material was wrapped snugly around the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: animal #1, #2, #3, #4, #5
Time point:
other: mean 24 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean 24 and 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal: animal #1, #2, #3, #4, #5
Time point:
other: mean 24 and 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: mean 24 and 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Slight erythema and edema were observed.
Other effects:
No data

Any other information on results incl. tables

Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of animals from the test

 

Score at time point / Reversibility

Erythema

Max. score 4

Oedema

Max. score 4

24 h

1 / 1 / 1 / 1 / 1 / 1

0 / 0 / 0 / 0 / 0 / 0

72 h

1 / 1 / 1 / 1 / 1 / 0

1 / 1 / 1 / 1 / 1 / 0

Average 24h and 72h

1 / 1 / 1 / 1 / 1 / 0.5

0.5 / 0.5 / 0.5 / 0.5 / 0.5 / 0

Reversibility*)

n.c. (animal #1, #2, #3, #4, #5)

n.c. (animal #1, #2, #3, #4, #5)

Average time for reversion

-

-

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Slightly irritating Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008.
Executive summary:

In a dermal irritation study performed according to US-FHSA guideline, 0.5 g of undiluted test material was dermally applied on the intact side surface of 6 albino rabbits. Test sites were covered with an occlusive dressing for 24 h. Skin irritation was assessed and scored according to the Draize scale at 24 and 72 h after the removal of the patch.

Under the test conditions, the test material induced slight erythema and oedema. Although reversibility was not assessed, responses were minimal at the 72 -hour time points. According to the CLP Guidance, it is therefore possible to use this study for classification by calculating the mean values for erythema and oedema on the basis of 24 and 72 -h time points.

The individual scores for each animal within 2 scoring times (24 and 72 hours) were 1 / 1 / 1 / 1 / 1 / 0.5 for erythema and 0.5 / 0.5 / 0.5 / 0.5 / 0.5 / 0 for oedema.

Therefore, the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.