Registration Dossier
Registration Dossier
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EC number: 203-694-5 | CAS number: 109-67-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12.7.1982-26.7.1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Fully documented, non GLP Study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No stepwise approach was adopted. Only the average weight of the test animals is given, and not the weight at the beginning and end of the test.
- Principles of method if other than guideline:
- In addition to the stated guideline, the test substance was applied to damaged skin to investigate systemic effects.
- GLP compliance:
- no
Test material
- Reference substance name:
- Pent-1-ene
- EC Number:
- 203-694-5
- EC Name:
- Pent-1-ene
- Cas Number:
- 109-67-1
- Molecular formula:
- C5H10
- IUPAC Name:
- pent-1-ene
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Pentene-1
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Russian (Albino)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Asta-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: 10 - 11 months
- Weight: 2.7 - 2.9 kg
- Housing: single
- Diet (e.g. ad libitum): Standardized feed for test animals ALTROMIN
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 days
- gender: female
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1°C
- Humidity (%): 50 - 60 %
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observation after 1, 24, 48 and 72 hours
- Number of animals:
- 3 female animals tested
- Details on study design:
- TEST SITE
- Area of exposure:
- % coverage: 100%
- Type of wrap if used: 6.25cm2 linen piece, covered by a synthetic self-adhesive strip; subsequently the patches were covered by a bandage (acrylastic)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
Values for erythema and eschar formation as well as oedema formation were averaged for all animals and summed up. The sum resulted from 16 averages and was divided by 8 to obtain the primary irritation index:
0.0 - 0.5: non irritating
0.6 - 3.0: slightly irritating
3.1 - 5.0: moderately irritating
5.1 - 8.0: strongly irritating
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- # animals 1-3; intact and scarified skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as no effect
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- #animals 1-3; intact and scarified skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as no effect
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No erythema or oedema formation was observed on any of the test animals at any observation time. Merely horny skin callus developed on the intact and scarified skin in the second observation period.
- Other effects:
- No systemic toxicity effects were observed after dermal application of the product.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, 1-pentene is not classified for skin irritation according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a dermal irritation study performed similarly to the EU Method B4, 0.5 mL of test material was applied on intact and scarrified skin of 3 female Russian rabbits. Test sites were covered with an occlusive dressing for 4 hours. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 h after the removal of the patch.
No reaction on intact or scarrified skin was found. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 0.0 / 0.0 / 0.0 for erythema and oedema.
Based on the available data, the test item Pentene-1 was not skin irritant. No additional self-classification is proposed regarding skin irritation according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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