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EC number: 300-202-1 | CAS number: 93924-10-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- In vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-06-11 to 1985-06-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because the study was carried out closely following OECD Guideline 404 and was GLP compliant.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- In vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1985-06-11 to 1985-06-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because the study was carried out closely following OECD Guideline 404 and was GLP compliant.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sittingbourne Research Centre breeding colony
- Age at study initiation: 4 to 9 months old
- Weight at study initiation: 4.23 kilograms to 4.57 kilograms
- Housing: Individual
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum: Ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 19°C
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From: 11 June 1985 To: 27 June 1985 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume): 0.5 millilitre
- Concentration (if solution): Undiluted (100%) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- Three male, three female
- Details on study design:
- TEST SITE
- Area of exposure: 2 centimetres x 2 centimetres
- % coverage: 100%
- Type of wrap if used: Elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
- Time after start of exposure: 4 hours
SCORING SYSTEM: Scored for erythema and oedema on a graded scale of 0 to 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Application of the test material resulted in no skin reaction and erythema and oedema mean scores of 0 at all observation times.
- Other effects:
- None reported
- Interpretation of results:
- other: Not classified through EU CLP; not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Application of the test material resulted in no skin reaction and erythema and oedema mean scores of 0 at all observation times. The test material was classified as non-irritating.
- Executive summary:
In a primary dermal irritation study, young adultwhite rabbits (3/sex) were dermally exposed to 0.5 millilitres of 1-hexene, 99.4% pure, for 4 hours to 2 centimetres x 2 centimetres of body surface area. Animals then were observed for 7 days. Irritation was scored based on OECD guidelines, on a scale of 0 to 4.
The application of 1 -hexene resulted in no skin reactions, with a mean irritation score of 0 for erythema and oedema at all time points.In this study, 1-hexene is not a dermal irritant.
This study received a Klimisch score of 1and is classified asreliable without restriction, because the study was carried out closely following OECD Guideline 404 and was GLP compliant.
The test material was classified as non-irritating because the group mean was 0 for both erythema and oedema at 24, 48, and 72 hours.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hex-1-ene
- EC Number:
- 209-753-1
- EC Name:
- Hex-1-ene
- Cas Number:
- 592-41-6
- Molecular formula:
- C6H12
- IUPAC Name:
- hex-1-ene
- Details on test material:
- - Name of test material (as cited in study report): SHOP C6 linear alpha olefins (1-hexene)
- Substance type: C6 alpha olefin
- Physical state: Liquid
- Analytical purity: 99.4% C6
- Impurities (identity and concentrations): 0.3% C4, 0.3% C8
- Composition of test material, percentage of components: Water 90 parts per million, colour (Hazen) <5 parts per million, carbonyl 6 parts per million, peroxide < 0.2 parts per million; C6 99.4%, C4 0.3%, C8 0.3%, beta olefins 2.4%, branched olefins 0.9%, paraffins 0.01%, total alpha olefins 96.1%
- Lot/batch No.: A6002
- Stability under test conditions: Stable over 13 months
- Storage condition of test material: In the dark at ambient temperature under nitrogen
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sittingbourne Research Centre breeding colony
- Age at study initiation: 4 to 9 months old
- Weight at study initiation: 4.23 kilograms to 4.57 kilograms
- Housing: Individual
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum: Ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 19°C
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From: 11 June 1985 To: 27 June 1985
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume): 0.5 millilitre
- Concentration (if solution): Undiluted (100%) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- Three male, three female
- Details on study design:
- TEST SITE
- Area of exposure: 2 centimetres x 2 centimetres
- % coverage: 100%
- Type of wrap if used: Elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
- Time after start of exposure: 4 hours
SCORING SYSTEM: Scored for erythema and oedema on a graded scale of 0 to 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Application of the test material resulted in no skin reaction and erythema and oedema mean scores of 0 at all observation times.
- Other effects:
- None reported
Any other information on results incl. tables
The test material was classified as non-irritating because the group mean was 0 for both erythema and oedema at 24, 48, and 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified through EU CLP; not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Application of the test material resulted in no skin reaction and erythema and oedema mean scores of 0 at all observation times. The test material was classified as non-irritating.
- Executive summary:
In a primary dermal irritation study, young adultwhite rabbits (3/sex) were dermally exposed to 0.5 millilitres of 1-hexene, 99.4% pure, for 4 hours to 2 centimetres x 2 centimetres of body surface area. Animals then were observed for 7 days. Irritation was scored based on OECD guidelines, on a scale of 0 to 4.
The application of 1 -hexene resulted in no skin reactions, with a mean irritation score of 0 for erythema and oedema at all time points.In this study, 1-hexene is not a dermal irritant.
This study received a Klimisch score of 1and is classified asreliable without restriction, because the study was carried out closely following OECD Guideline 404 and was GLP compliant.
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