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EC number: 437-760-1 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Particle size distribution (Granulometry)
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 18 to 28, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline 404 without any deviation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected on September 22, 1999 / signed on January 18, 2000
Test material
- Reference substance name:
- -
- EC Number:
- 437-760-1
- EC Name:
- -
- Cas Number:
- 285977-85-7
- Molecular formula:
- C12H16O
- IUPAC Name:
- (2,5-dimethyl-2,3-dihydro-1H-inden-2-yl)methanol
- Test material form:
- solid
- Details on test material:
- - Physical state: White solid (but some samples were received as liquid, due to stability in supercooled state)
- Storage condition of test material: At room temperature, protected from light and under nitrogen atmosphere
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: No data available
- Weight at study initiation: 2.5 ± 0.2 kg
- Housing: Animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
- Diet: 112 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 micron), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- Humidity: 30–70%
- Air changes: Approximately 12 cycles/hour of filtered, non-recycled air.
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: January 18, 2000 To: January 28, 2000
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: moistened with water
- Controls:
- other: untreated skin served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 mg (ground to a fine powder using a mortar and pestle)
- Purified water was used to moisten the test substance and ensure good contact with the skin - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observations at 1, 24, 48 and 72 hours and daily as needed up to 14 days after removal of the dressing.
- Number of animals:
- 3 male animals
- Details on study design:
- TEST SITE
- Area of exposure: Right flank
- % coverage: no data available
- Type of wrap if used: The test substance and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: After removal of the dressing, any residual test substance was wiped off by means of a dry gauze pad.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale, as described in OECD Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of weak irritation
- Remarks:
- A well-defined erythema (score 2) was noted on Day 1, then a very slight erythema (score 1) persisted up to Day 5. Dryness of the skin was recorded between Day 6 and Day 10
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Remarks:
- A very slight erythema was observed on Day 1 and 2 only
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- In one animal, a well-defined erythema (grade 2) was noted on day 1, then a very slight erythema (grade 1) persisted up to day 5. Dryness of the skin was recorded between day 6 and day 10.
In a second animal, a very slight erythema (grade 1) was observed on days 1 and 2 only.
No cutaneous reactions were observed in the third animal. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time
Score at time point |
Erythema (Animal no 1 / 2 / 3) Max. score 4 |
Oedema (Animal no 1 / 2 / 3) Max. score 4 |
1 h (D1) |
2 / 1 / 0 |
0 / 0 / 0 |
24 h (D2) |
1 / 1 / 0 |
0 / 0 / 0 |
48 h (D3) |
1 / 0 / 0 |
0 / 0 / 0 |
72 h (D4) |
1 / 0 / 0 |
0 / 0 / 0 |
D5 |
1 / - / - |
0 / - / - |
D6 |
0 / - / - |
0 / - / - |
D7 |
0 / - / - |
0 / - / - |
D8 |
0 / - / - |
0 / - / - |
D9 |
0 / - / - |
0 / - / - |
D10 |
0 / - / - |
0 / - / - |
D11 |
0 / - / - |
0 / - / - |
Average 24, 48 and 72 h |
1.0 / 0.3 / 0.0 |
0.0 / 0.0 / 0.0 |
-:Cutaneous examination not performed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Under the test conditions, test material is not classified as irritating to skin according to the annex I of the Regulation EC No. 1272/2008 (CLP) and of the GHS.
- Executive summary:
In a primary dermal irritation study performed according to the OECD Guideline No. 404/EU Method B.4, and in compliance with GLP, 500 mg of test material moistened with purified water was applied on the clipped skin of the right flank area of 3 male New Zealand White rabbits. Test sites were covered with a semi-occlusive dressing for 4 h. The untreated skin served as control. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48, 72 hours after removal of the dressing and then daily until reversibility of cutaneous reactions.
In one animal, a well-defined erythema was noted on day 1, then a very slight erythema persisted up to day 5. Dryness of the skin was recorded between day 6 and day 10. In a second animal, a very slight erythema was observed on days 1 and 2 only. No cutaneous reactions were observed in the third animal. Mean scores over 24, 48 and 72 hours for each animal were 1.0, 0.3 and 0.0 for erythema and 0.0, 0.0 and 0.0 for oedema.
Therefore, test material is not classified as irritating to skin according to the annex I of the Regulation EC No. 1272/2008 (CLP) and of the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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