Registration Dossier
Registration Dossier
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EC number: 215-553-5 | CAS number: 1330-86-5
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Occlusive dressing and prolonged exposure period (24 h). No details on test animals and environmental conditions.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
- Reference Type:
- secondary source
- Title:
- ECB IUCLID set dihexyl adipate
- Author:
- ECB
- Year:
- 2 000
- Bibliographic source:
- EUROPEAN COMMISION – European Chemicals Bureau
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive dressing and prolonged exposure period (24 h); no details on test animals and environmental conditions
- GLP compliance:
- no
Test material
- Reference substance name:
- Dihexyl adipate
- EC Number:
- 203-757-7
- EC Name:
- Dihexyl adipate
- Cas Number:
- 110-33-8
- Molecular formula:
- C18H34O4
- IUPAC Name:
- dihexyl adipate
- Details on test material:
- - Name of test material (as cited in study report): Di-m-Hexyl adipate
- Physical state: liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 days
Reading time points: 1, 24, 48, 72, 120 h (5 days) and 168 h (7 days) - Number of animals:
- 3 (2 males and 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: The test substance was applied on the skin under a one inch by one inch square patch (2.54 cm x 2.54 cm).
- Type of wrap if used: The patch was held in place with an adhesive tape and the trunk of each animal was wrapped with plastic stripes to retard evaporation.
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:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 120 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 120 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 120 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- At the 1 h reading, no skin reactions were observed in the treated animals. Very slight to slight erythema and very slight edema were observed 24 and 48 h post-application, whereas only very slight erythema and no edema were noted at the 72 h reading time point. Erythema were fully reversible within 5 days after test substance application and no further reactions were observed after 7 days.
- Other effects:
- The sample had a slight defatting effect causing the skin to flake off in 7 to 10 days after application. There was no injury in depth.
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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