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EC number: 297-462-0 | CAS number: 93572-32-8
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:
- 11 Jan 1999 - 11 Mar 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: M.A.F.F. N° 4200 (1985)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerides, C16-18 mono- and di-
- EC Number:
- 286-490-9
- EC Name:
- Glycerides, C16-18 mono- and di-
- Cas Number:
- 85251-77-0
- IUPAC Name:
- 85251-77-0
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: white powder
- Analytical purity: considered as 100 % for the study
- Batch no.: 21150
- Storage conditions: at room temperature
- Expiry date: 2000-08-01
- Other: pH = 5.8
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand rabbit, NZW I.N.R.A. A9077
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chalaronne, France
- Age at study initiation: about 3 months
- Weight at study initiation: 2.23-2.40 kg
- Housing: barrier protected unit, individually in stainless steel cages
- Diet: pelleted complete rabbit diet 112 C-10 (Usine d'Alimentation Rationnelle, Epinay-sur-Orge, France), 150 g/d per animal
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3
- Humidity (%): > 45%
- Air changes (per hr): min. 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- other: sterile Codex liquid paraffin
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g prepared as a paste with 0.21 g of sterile Codex liquid paraffin.
The paste was administered within 4 hours of preparation.
VEHICLE
- Amount applied: 0.21 g sterile Codex liquid paraffin
- Lot/batch no.: T0122B
- Expiry date: 1999-12-01 - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm (about 6 cm²) gauze pad
- Type of wrap if used: the gauze pad was held in contact with the skin with a perforated tape and wrapped with a crimped gauze bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm tap water was used to remove the excess of test article.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- No further local or systemic effects were observed.
Any other information on results incl. tables
Table 1. Results of skin irritation study
Observation time |
Rabbit no. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
24 h |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
48 h |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
Table 2. Calculation of mean scores
|
Rabbit no. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
Mean value 24 + 48 + 72 h |
0.33 |
0 |
0 |
0 |
0.67 |
0 |
0 |
0 |
1 |
0 |
1 |
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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