Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: Skin irritation:  Isobornyl acetate is not irritating to skin. 
Eye irritation: Isobornyl acetate is not irritating for eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 9th to 16th, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to OECD guideline with GLP.
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:
other: New Zealand albino
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 of ligth a day

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0,5 mL/test
Duration of treatment / exposure:
4 hours
Observation period:
The assessments were made 30-60 minutes, and 24, 48 and 72 hours after the removal of the patch. Then, after 7 days.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with tap water

SCORING SYSTEM: Erythema and eschar and oedema: a rating scale from 0 to 4.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 30-60 min to 7 days
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 30-60 min
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 7 d
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 30-60 min
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 7 d
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 30-60 min to 7 days
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 30-60 min
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 7 d
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 30-60 min
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 48 h to 7 days
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
irritating
Conclusions:
Isobornyl acetate is irritating to skin
Executive summary:
The skin irritation test was performed according to OECD 404 guideline. Isobornyl acetate was irritating for skin. The substance should be classified as R38 - but does not need to be classified as skin irritant according to CLP criteria.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: A scientific review (peer reviewed). No data on GLP. The described method is not equivalent to OECG guideline.
Principles of method if other than guideline:
Isobornyl acetate was applied full strengh to intact or abraded rabbit skin for 24 hours under occlusion.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
other: intact or abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
24 h
Irritation parameter:
other: No detailed information
Basis:
mean
Time point:
24/48/72 h

The substance has been described as mildly irritating to skin.

Interpretation of results:
other: mildly irritating
Conclusions:
The substance was mildly irritating to skin.
Executive summary:

The test of skin irritancy of isobornyl acetate was performed. The substance was applied full strength to intact or abraded rabbit skin for 24 hours under occlusion. Isobornyl acetate was mildly irritating to skin.

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:
experimental study
Adequacy of study:
key study
Study period:
February 23th to 26th, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to OECD guideline with GLP.
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:
other: New Zealand albine
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 of light a day

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL/eye
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): yes

SCORING SYSTEM: damage to the cornea, iris and conjunctiva were evaluated numerically, by a rating system.

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #2
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #2
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #2
Time point:
other: 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #3
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #3
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival swelling
Basis:
animal #3
Time point:
other: 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #1
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #1
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #1
Time point:
other: 48 and 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #2
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #3
Time point:
other: 1 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
other: all animals
Time point:
other: all time points
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Remarks:
corneal opacity
Basis:
other: all animals
Time point:
other: all time points
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within:
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Interpretation of results:
not irritating
Conclusions:
Isobornyl acetate is not irritating for eyes.
Executive summary:
The eye irritation test of isobornyl acetate was performed in 3 rabbits according to OECG guideline. The results shows that the substance has not to be not classified as irritating to eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation:

Key study:

The skin irritation test was performed according to OECD 404 guideline. Isobornyl acetate was irritating for skin. The substance should be classified as R38 - irritating to skin but is not classified under CLP criteria.

Supporting study:

In the test of skin irritancy, Isobornyl acetate was applied full strength to intact or abraded rabbit skin for 24 hours under occlusion. The substance was mildly irritating to skin.

Eye irritation:

Key study:

The eye irritation test of Isobornyl acetate was performed in 3 rabbits according to OECD guideline. The result shows that the substance has to be not classified as irritating for eyes.

Justification for classification or non-classification

Isobornyl acetate should be classified as R38 - irritating to skin according to DSD – DPD but does not classified as skin irritant according to CLP criteria.