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Registration Dossier
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EC number: 701-392-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- In vivo testing previously conducted before in vitro rules came into force
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980-12-9 to 1980-12-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- 24 hour exposure and termination at 72 hours without evidence of reversibility
- Justification for type of information:
- Test conducted prior to the introduction of in vitro methods.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Section 1500.41- Federal Hazardous Substances Act Regulations - 16 CFR
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24 hour exposure to the test material
- Principles of method if other than guideline:
- Six albino rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24h. Treated areas were examined at 24h after treatment and scoring using the Draize method was done at 72h after treatment.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-tetradecyloxirane, reaction products with boric acid
- EC Number:
- 701-392-2
- IUPAC Name:
- 2-tetradecyloxirane, reaction products with boric acid
- Test material form:
- not specified
- Details on test material:
- - Date of receipt: 1980-11-19
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 24 hour
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back
- % coverage: not specified
- Type of wrap if used: gauze patch covered by impervious material.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #1
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #1
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #2
- Time point:
- other: Mean 24/72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #2
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #3
- Time point:
- other: mean 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #3
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #4
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #4
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #5
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #5
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #6
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #6
- Time point:
- other: mean 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #1
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #1
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #2
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #2
- Time point:
- other: mean 24/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #3
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #3
- Time point:
- other: mean 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #4
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #4
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #5
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #5
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #6
- Time point:
- other: mean 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #6
- Time point:
- other: mean 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - Very slight erythema was observed at the intact skin in two and three animals at 24 and 72 hours, respectively. Whereas in abraded skin, very slight erythema was observed in three and four animals at 24 and 72 hours, respectively. At 24 and 72 hours, very slight edema was observed in intact skin of three animals. At 24 and 72 hours, very slight edema was observed in abraded skin of two and three animals, respectively; whereas slight edema was observed in abraded skin of one animal at 24 and 72 hours.
- There was no evidence of reversibility over the limited timeframe of the study. - Other effects:
- No data
Any other information on results incl. tables
Table 7.3.1/1: Primary skin irritation
Erythema and Eschar Formation |
Reading (hrs) |
Rabbit number |
Average |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||
Intact Skin |
24 |
1 |
1 |
0 |
0 |
0 |
0 |
0.33 |
Intact Skin |
72 |
1 |
1 |
1 |
0 |
0 |
0 |
0.50 |
Abraded Skin |
24 |
1 |
1 |
1 |
0 |
0 |
0 |
0.50 |
Abraded Skin |
72 |
1 |
1 |
1 |
0 |
0 |
1 |
0.67 |
Subtotal |
2.00 |
|||||||
Edema Formation |
||||||||
Intact Skin |
24 |
1 |
1 |
1 |
0 |
0 |
0 |
0.50 |
Intact Skin |
72 |
1 |
1 |
1 |
0 |
0 |
0 |
0.50 |
Abraded Skin |
24 |
1 |
2 |
1 |
0 |
0 |
0 |
0.67 |
Abraded Skin |
72 |
1 |
2 |
1 |
0 |
0 |
1 |
0.83 |
Subtotal |
2.50 |
|||||||
Total |
4.50 |
|||||||
Primary irritation score |
1.13 |
|||||||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not irritating to the skin of rabbits under the conditions of the study. In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin irritation.
- Executive summary:
Test Guidance
Skin irritation study performed by a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations.
Method and Material
Six albino rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.
Results
Very slight erythema was observed at the intact skin in two and three animals at 24 and 72 hours, respectively. Whereas in abraded skin, very slight erythema was observed in three and four animals at 24 and 72 hours, respectively. At 24 and 72 hours, very slight edema was observed in intact skin of three animals. At 24 and 72 hours, very slight edema was observed in abraded skin of two and three animals, respectively; whereas slight edema was observed in abraded skin of one animal at 24 and 72 hours. There was no evidence of reversibility over the limited timeframe of the study.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin irritation.
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