Bicyclo[2.2.1]heptan-2-ol, 1,3,3-trimethyl-, 2-acetate, (1R,2R,4S)-rel-

Endpoint summary

Description of key information

Skin irritation: Key study: Test method OECD 404.GLP study: Based on the read-across approach, 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.
Eye irritation: Key study: Test method OECD 405.GLP study: Based on the read-across approach, dextro alpha fenchyl acetate was determined to be not irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

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

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

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.

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.

The data matrix is included in the reporting format attached.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

23 February 1988 - 26 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 405. GLP study.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, konventionelle Zucht
- Age at study initiation: 3-5 months
- Weight at study initiation: 2,3 - 3,0 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 ± 3ºC
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 24, 48 and 72 hours after application of the test.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Physiological saline solution (37 ° C)
- Time after start of exposure: 24 h

SCORING SYSTEM: Grading of ocular lesions in accordance with OECD 405.

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24-72h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0

Max. score:

3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0

Max. score:

2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

After one hour exposure, the skins of the animals showed from very little binding to distinct swelling and a diffuse red color. Between 24 and 48 hours after exposure very light, barely perceptible, swelling and redness of the conjunctivae was observed. There effects were fully reversible by 72 hours after exposure.


One hour revealed the binding very light skins of animals to clear swelling and a diffuse crimson-red to bright red diffuse color. Have 24 hours to 48 hours some very light barely perceptible redness and swelling of the conjunctiva are noted. 72 hours were all lovely reversible phenomena.

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 is determined to be not irritating to the eye.

Executive summary:

An in-vivo eye irritation test was performed on the analogue substance isobornyl acetate according to OECD Guideline 405. The right eye of three New Zealand White rabbits were exposure to 0.1 mL (unchanged) test sample. The other one was used as control. The effects were observed after 1, 24, 48 and 72 hours exposure. Two rabbits showed a chemosis score of 0.33 (mean 24 -72h) which was fully reversible after 48 hours of exposure. One rabbit showed a conjunctivae score of 0.66 (mean 24 -72h) which was fully reversible after 72 hours of exposure. Based on these results, the read-across approach was applied and dextro alpha fenchyl acetate was determined to be not irritating to the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation: Key study: Read-across approach from experimental data on the analogue isobornyl acetate:

An in-vivo skin irritation test was performed on the analogue substance isobornyl acetate according to OECD 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.

Eye irritation: Key study: Read-across approach from experimental data on the analogue isobornyl acetate:

An in-vivo eye irritation test was performed on the analogue substance isobornyl acetate according to OECD Guideline 405. The right eye of three New Zealand White rabbits were exposure to 0.1 mL (unchanged) test sample. The other one was used as control. The effects were observed after 1, 24, 48 and 72 hours exposure. Two rabbits showed a chemosis score of 0.33 (mean 24 -72h) which was fully reversible after 48 hours of exposure. One rabbit showed a conjunctivae score of 0.66 (mean 24 -72h) which was fully reversible after 72 hours of exposure. Based on these results, the read-across approach was applied and dextro alpha fenchyl acetate was determined to be not irritating to the eye.

Justification for selection of skin irritation / corrosion endpoint:
Only one study available

Justification for selection of eye irritation endpoint:
Only one study available.

Justification for classification or non-classification

Based on the available information, the substance is not classified for skin irritation and eye irritation in accordance with CLP Regulation (EC) no. 1272/2008. Besides, it is classified as irritating to skin (Xi, R38) according to Directive 67/548/EEC.