Registration Dossier
Registration Dossier
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EC number: 204-727-6 | CAS number: 125-12-2
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- 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
- 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:
- 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
- Physical state: liquid
- Analytical purity: 93.5 – 95.5 % Isobornylacetat
- Impurities (identity and concentrations): other terpene esters and camphene
- Composition of test material, percentage of components:
93.5 – 95.5 % Isobornylacetat
2.4 - 3.2 % Isofenchylacetat
0.5 - 0.8 % Pseudobornylacetat
0.4 - 0.7 % Fenchylacetat
0.4 - 0.8 % Isoborneol
0.2 - 0.8 % Camphen
- Lot/batch No.: Op. 211
- Storage condition of test material: in the dark, at 22ºC
Constituent 1
Test animals
- 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
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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
Applicant's summary and conclusion
- 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.
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