Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
9 February 1988 - 16 February 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The analogue isobornyl acetate which shares the same functional groups with dextro alpha fenchyl acetate also has comparable values for the relevant molecular properties. Test method according to OECD 404. GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
EC Number:
204-727-6
EC Name:
Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
Cas Number:
125-12-2
Molecular formula:
C12H20O2
IUPAC Name:
(1S,2S,4S) 1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
Details on test material:
- Name of test material (as cited in study report): Isobornylacetat-Extra
- Molecular formula (if other than submission substance): C12H20O2
- Molecular weight (if other than submission substance): 196.286
- Smiles notation (if other than submission substance): CC(=O)O[C@H]1C[C@@H]2CC[C@@]1(C)C2(C)C
- InChl (if other than submission substance): 1/C12H20O2/c1-8(13)14-10-7-9-5-6-12(10,4)11(9,2)3/h9-10H,5-7H2,1-4H3
- Structural formula attached as image file (if other than submission substance): see Fig.
- Physical state: Liquid
- Analytical purity: 93.5 – 95.5 %
- Impurities (identity and concentrations): other terpene esters and camphene
- Lot/batch No.: Op. 211
- Storage condition of test material: in the dark, at 22ºC

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, konventionelle Zucht
- Age at study initiation: 3-5 weeks
- Weight at study initiation: 2,0 - 2,4 kg
- Housing: in air-conditioned rooms in individual cages (battery cages)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
After 30-60 min, 24, 48 and 72 hours and 7 days of patch removal.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm,
- Type of wrap if used: cellulose patch, covered with a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Tap water

SCORING SYSTEM: Grading of skin reactions according to OECD 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-72
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
After 72h and 7 days from the removal of patch, the following effects were observed: dry skin, brittle skin, from fine-to-rough scaling surfaces.
One animal showed pin skin after 7 days.

Any other information on results incl. tables

The data matrix is included in the reporting format attached.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the read-across approach from experimental data on the analogue isobornyl acetate, dextro alpha fenchyl acetate was determined to be not irritating to the skin in accordance with CLP Regulation (EC) no. 1272/2008 and as irritating to the skin (Xi, R38) according to Directive 67/548/EEC.
Executive summary:

An in-vivo skin irritation test was performed on the analogue substance isobornyl acetate according to OECD Guideline 404. Three New Zealand White rabbits were exposed to 0.5 mL (unchanged) test sample under semi-occlusive conditions for 4 hours. After patch removal, the rabbits were observed at 30 -60 min, 24, 48 and 72 hours and 7 days. Two rabbits showed erythema score of 2 at mean 24 -72h time period, which was fully reversible by day 7. No edema was observed. Based on these results, the read-across approach was applied and dextro alpha fenchyl acetate was determined to be not irritating to the skin in accordance with CLP Regulation (EC) no. 1272/2008 and as irritating to the skin (Xi, R38) according to Directive 67/548/EEC.