Registration Dossier
Registration Dossier
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EC number: 950-299-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Cited in draft RAR (EU, 2008) as performed according to OECD Guidelines
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- use of occlusive rather than semi-occlusive conditions and shaved rather than closely clipped skin.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Alkanes, C14-17, chloro
- EC Number:
- 287-477-0
- EC Name:
- Alkanes, C14-17, chloro
- Cas Number:
- 85535-85-9
- Molecular formula:
- Substance is a range of chlorinated isomers of C14 to C17 paraffin
- IUPAC Name:
- Alkanes, C14-17, chloro
- Details on test material:
- - Name of test material (as cited in study report): Chloroparaffin 40G
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): epoxy stabiliser B74 (1%)
- Composition of test material, percentage of components: C14-17 chlorinated paraffin (40% chlorinated)
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:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 14 days after application
- Number of animals:
- 6
- Details on study design:
- No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: C14-17 chlorinated paraffin (40% chlorinated)
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: C14-17 chlorinated paraffin (40% chlorinated)
- Irritant / corrosive response data:
- no data
- Other effects:
- Scales were seen on the 6th to 10th days after exposure, preceded by drying and hardness of the skin at 72 hours. Peeling was observed on days 6 to 8.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: other: Expert judgement
- Conclusions:
- No corrosion was seen to the skin of rabbits treated with a single (4 h) application of Chloroparaffin 40G (a C14-17 chlorinated paraffin; 40% chlorination, containing 1% epoxy stabiliser) under occlusive conditions. Only mild irritation was seen, characterised by slight erythema and slight oedema at 24-72 h, drying and hardness at 72 h, peeling of presumably the outermost layers of the skin on days 6 to 8 and the presence of scales on days 6 to 10 after application.
- Executive summary:
Chloroparaffin 40G (a C14-17 chlorinated n-paraffin, 40% chlorinated; containing 1% epoxy stabiliser B74), was applied undiluted to the shaved skin of a group of 6 rabbits under occlusive conditions (0.5 ml for 4 h). Observation of the skin was continued for up to 14 days.
Erythema and oedema were seen on the treated skin at 24 to 72 h (mean score 1.5 and 0.6 respectively) and "dryness and hardness" noted at 72 h. Peeling, presumably of the outermost layers of the skin, was seen at days 6 to 8 and scales were seen on the skin on days 6 to 10. No corrosion was seen.
Under the conditions of this study, the test material is considered to cause slight skin irritation to rabbits on single exposure.
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