Registration Dossier
Registration Dossier
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EC number: 814-059-2 | CAS number: 68680-98-8
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:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- See read-across justification attached in section 13.2
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Tetrahydrogeraniol
- Physical state: colourless liquid
- Storage condition of test material: in the dark at room temperature - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gorseside Rabbits, Gorse, Northchurch, Berkhamsted, Hertfordshire
- Housing: individually housed in grid bottomed metal cages
- Diet: ad libitum antibiotic free rabbit diet (SQC standard rabbit pellets produced by Special Diets Services, Witham, Essex)
- Water: drinking water, ad libitum
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21
- Humidity (%): 37-68
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- - Amount(s) applied: 0.5 ml
- Concentration: 100 % - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: clipped dorsal skin
- Type of wrap if used: compound applied to 2.5 cm square of surgical lint
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in water at 37°C.
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline
EVALUATION:
- Time schedule: 1, 24, 48, 72 h, 7 , 14 days after patch removal - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days in 2/3 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days (1/3 animals); 14 days (2/3 animals)
- Irritant / corrosive response data:
- See table 1.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- According to the study, the test substance was found to be corrosive and is classified as Category 2.
Table 1:
A well defined irritation which was significant at day 7 was noted.
Recovery had generally occured within 14 days
| Readings | Animal | Erythema | Edema | Further findings |
| 1h | 1 | 1 | 0 | - |
| 2 | 1 | 1 | - | |
| 3 | 2 | 1 | - | |
| 24h | 1 | 2 | 1 | - |
| 2 | 1 | 1 | - | |
| 3 | 2 | 1 | - | |
| 48h | 1 | 2 | 1 | - |
| 2 | 2 | 1 | - | |
| 3 | 2 | 1 | - | |
| 72h | 1 | 2 | 1 | - |
| 2 | 2 | 1 | - | |
| 3 | 2 | 1 | - | |
| 7 d | 1 | 2 | 1 | Marked desquamation |
| 2 | 1 | 0 | Marked desquamation | |
| 3 | 2 | 2 | Marked desquamation | |
| 14d | 1 | 1 | 0 | - |
| 2 | 0 | 0 | slight desquamation | |
| 3 | 1 | 0 | - | |
| Mean (24h-72h) | 1 | 2,0 | 1,0 | |
| 2 | 1,7 | 1,0 | ||
| 3 | 2,0 | 1,0 | ||
| Mean (24h-72h) | all animals | 1,9 | 1,0 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,7-dimethyloctan-1-ol
- EC Number:
- 203-374-5
- EC Name:
- 3,7-dimethyloctan-1-ol
- Cas Number:
- 106-21-8
- Molecular formula:
- C10H22O
- IUPAC Name:
- 3,7-dimethyloctan-1-ol
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Tetrahydrogeraniol
- Physical state: colourless liquid
- Storage condition of test material: in the dark at room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gorseside Rabbits, Gorse, Northchurch, Berkhamsted, Hertfordshire
- Housing: individually housed in grid bottomed metal cages
- Diet: ad libitum antibiotic free rabbit diet (SQC standard rabbit pellets produced by Special Diets Services, Witham, Essex)
- Water: drinking water, ad libitum
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21
- Humidity (%): 37-68
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- - Amount(s) applied: 0.5 ml
- Concentration: 100 % - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: clipped dorsal skin
- Type of wrap if used: compound applied to 2.5 cm square of surgical lint
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in water at 37°C.
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline
EVALUATION:
- Time schedule: 1, 24, 48, 72 h, 7 , 14 days after patch removal
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days in 2/3 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days (1/3 animals); 14 days (2/3 animals)
- Irritant / corrosive response data:
- See table 1.
Any other information on results incl. tables
Table 1:
A well defined irritation which was significant at day 7 was noted.
Recovery had generally occured within 14 days
| Readings | Animal | Erythema | Edema | Further findings |
| 1h | 1 | 1 | 0 | - |
| 2 | 1 | 1 | - | |
| 3 | 2 | 1 | - | |
| 24h | 1 | 2 | 1 | - |
| 2 | 1 | 1 | - | |
| 3 | 2 | 1 | - | |
| 48h | 1 | 2 | 1 | - |
| 2 | 2 | 1 | - | |
| 3 | 2 | 1 | - | |
| 72h | 1 | 2 | 1 | - |
| 2 | 2 | 1 | - | |
| 3 | 2 | 1 | - | |
| 7 d | 1 | 2 | 1 | Marked desquamation |
| 2 | 1 | 0 | Marked desquamation | |
| 3 | 2 | 2 | Marked desquamation | |
| 14d | 1 | 1 | 0 | - |
| 2 | 0 | 0 | slight desquamation | |
| 3 | 1 | 0 | - | |
| Mean (24h-72h) | 1 | 2,0 | 1,0 | |
| 2 | 1,7 | 1,0 | ||
| 3 | 2,0 | 1,0 | ||
| Mean (24h-72h) | all animals | 1,9 | 1,0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- According to the study, the test substance was found to be an irritant and is classified as Category 2.
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