Registration Dossier
Registration Dossier
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EC number: 203-518-7 | CAS number: 107-75-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable report performed according to current guidelines
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
- Reference Type:
- publication
- Title:
- Skin irritation and Corrosion: Reference Chemicals Data Bank
- Author:
- European Centre for Ecotoxicology and Toxicology of Chemicals
- Year:
- 1 995
- Bibliographic source:
- ECETOC Technical Report No. 66, p78
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 7-hydroxycitronellal
- EC Number:
- 203-518-7
- EC Name:
- 7-hydroxycitronellal
- Cas Number:
- 107-75-5
- Molecular formula:
- C10H20O2
- IUPAC Name:
- 7-hydroxy-3,7-dimethyloctanal
- Details on test material:
- - Name of test material (as cited in study report): Hydroxycitronellal; 592350.1; 96/8503
- Analytical purity: 98.7% (taken from the cited publication)
no further data given
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A. Smith, 7 Kydcomb Road, Warlingham, Surrey
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):18-22
- Humidity (%):42-65
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped, intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, 72 h; 7 d
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin
- Type of wrap if used: placed evenly over a 2.5 cm square of surgical lint B.P placed onto a 6 cm square area of clipped, intact dorsal skin. The lint patches were held in place by encircling the trunk of the animals with a length of 'Elastoplast' elastic adhesive bandage 10 cm wide.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with warm water
- Time after start of exposure: 4 h
SCORING SYSTEM:
Irritation was assessed and allocated a numerical value based on the following:
- Erythema and Eschar Formation
No erythema = 0;
Very slight erythema (barely perceptible) = 1;
Well-defined erythema = 2;
Moderate to severe erythema = 3;
Severe erythema (beet redness) to slight eschar formation (injuries in depth) = 4.
- Oedema Formation:
No oedema = 0;
Very slight oedema (barely perceptible) = 1;
Slight oedema (edges of area well-defined by definite raising) = 2;
Moderate oedema (raised approximately 1 mm) = 3;
Severe oedema (raised more than 1 mm and extending beyond area of exposure) = 4.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
Any other information on results incl. tables
| Readings | Animal | Erythema | Edema | Further findings |
| 1h | 1 | 1 | 0 | slight yellow staining |
| 2 | 0 | 0 | - | |
| 3 | 0 | 0 | - | |
| 4 | 1 | 0 | - | |
| 24h | 1 | 2 | 1 | - |
| 2 | 0 | 0 | - | |
| 3 | 1 | 0 | - | |
| 4 | 1 | 0 | - | |
| 48h | 1 | 2 | 0 | - |
| 2 | 0 | 0 | - | |
| 3 | 1 | 0 | - | |
| 4 | 1 | 0 | - | |
| 72h | 1 | 1 | 0 | - |
| 2 | 0 | 0 | - | |
| 3 | 0 | 0 | - | |
| 4 | 1 | 0 | - | |
| 7d | 1 | 0 | 0 | - |
| 2 | 0 | 0 | - | |
| 3 | 0 | 0 | very slight desquamation | |
| 4 | 0 | 0 | - | |
| Mean (24h-72h) | 1 | 1.7 | 0.3 | |
| 2 | 0 | 0 | ||
| 3 | 0.7 | 0 | ||
| 4 | 1 | 0 | ||
| Mean (24h-72h) | all animals | 0.8 | 0.1 |
Applicant's summary and conclusion
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