Registration Dossier
Registration Dossier
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EC number: 812-656-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 06 June - 23 June 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions (only few details on the test substance given)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Lack of details on test substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18, triesters with trimethylolpropane
- EC Number:
- 293-037-9
- EC Name:
- Fatty acids, C16-18, triesters with trimethylolpropane
- Cas Number:
- 91050-90-7
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: solid, white
- Analytical purity: not reported
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: 5-6 months
- Weight at study initiation: 2.4 kg (mean)
- Housing: individually in rabbit-battery
- Diet: Altromin 2023, ad libitum
- Water: tap water, ad libitum
- Acclimatisation: approx. 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48, 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: very slight erythema (grade 1) was seen at 24 and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: very slight erythema (grade 1) was seen at 24h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: very slight erythema (grade 1) was seen at 24 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: No edema observed
- Irritant / corrosive response data:
- All 3 animals displayed very slight erythema at reading time point 24 h; in one case (animal 1), erythema remained up to 48 h. The finding was fully reversible for all 3 animals with 48 to 72 h. No edema was seen.
Any other information on results incl. tables
Table 1: Erythema score
Animal Number |
1 h |
1 day |
2 days |
3 days |
1 |
0 |
1 |
1 |
0 |
2 |
0 |
1 |
0 |
0 |
3 |
0 |
1 |
0 |
0 |
Table 2: Edema Score
Animal Number |
1 h |
1 day |
2 days |
3 days |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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