Registration Dossier
Registration Dossier
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EC number: 307-301-9 | CAS number: 97593-01-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-07-26 to 1994-08-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it was conducted according to GLPs and OECD TG 404.
- 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: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1994-07-26 to 1994-08-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it was conducted according to GLPs and OECD TG 404.
- 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:
- according 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: Myrtle's Rabbitry Incorporated, Thompson Station, Tennessee
- Age at study initiation: Young adult
- Weight at study initiation: 2.717 to 3.009 kg
- Housing: Individual
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 21 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 1994-07-28 To: 1994-08-11 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6.25 cm2
- % coverage: No data
- Type of wrap if used: Gauze patch, cotton cloth and tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal: Mean of animals (1-3)
- Time point:
- 24/48/72 h
- Score:
- 1.56
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal: Mean of animals (1-3)
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: Mean of animals (1-3)
- Time point:
- 14 d
- Score:
- 2.2
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Erythema and oedema scores were calculated by averaging the scores for erythema and oedema for all animals at 24, 48 and 72 hours, respectively.
- Other effects:
- No physical or behavioural abnormalities were observed in any animal.
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- C16/18 alpha olefins, isomerized were classified as not irritating according to EU classification. The 24-72 hour average erythema score was 1.56 and the 24-72 hour average oedema score was 0.22.
- Executive summary:
In a primary dermal irritation study, young adultwhite rabbits (two males, one female) were dermally exposed to 0.5 mL of C16/18 isomerized alpha olefins for 4 hours to 6.25 cm2of the body. Animals then were observed for 14 days. Irritation was scored by the method of Draize (1959).
The test material produced well-defined erythema and very slight to slight oedema, which had all cleared by day 14 of observation. The 24-72 hour average erythema score was 1.56 and the 24-72 hour average oedema score was 0.22. In this study, C16/18 isomerized alpha olefin is not a dermal irritant based on EU classification.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to GLPs and OECD TG 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Alkenes, C16-18
- EC Number:
- 900-050-1
- IUPAC Name:
- Alkenes, C16-18
- Details on test material:
- - Name of test material (as cited in study report): C16/18 alpha olefins, isomerized
- Substance type: Alkenes C16-18
- Physical state: Liquid
- Analytical purity: Not reported
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry Incorporated, Thompson Station, Tennessee
- Age at study initiation: Young adult
- Weight at study initiation: 2.717 to 3.009 kg
- Housing: Individual
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 21 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 1994-07-28 To: 1994-08-11
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6.25 cm2
- % coverage: No data
- Type of wrap if used: Gauze patch, cotton cloth and tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: Mean of animals (1-3)
- Time point:
- 24/48/72 h
- Score:
- 1.56
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal: Mean of animals (1-3)
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: Mean of animals (1-3)
- Time point:
- 14 d
- Score:
- 2.2
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Erythema and oedema scores were calculated by averaging the scores for erythema and oedema for all animals at 24, 48 and 72 hours, respectively.
- Other effects:
- No physical or behavioural abnormalities were observed in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- C16/18 alpha olefins, isomerized were classified as not irritating according to EU classification. The 24-72 hour average erythema score was 1.56 and the 24-72 hour average oedema score was 0.22.
- Executive summary:
In a primary dermal irritation study, young adultwhite rabbits (two males, one female) were dermally exposed to 0.5 mL of C16/18 isomerized alpha olefins for 4 hours to 6.25 cm2of the body. Animals then were observed for 14 days. Irritation was scored by the method of Draize (1959).
The test material produced well-defined erythema and very slight to slight oedema, which had all cleared by day 14 of observation. The 24-72 hour average erythema score was 1.56 and the 24-72 hour average oedema score was 0.22. In this study, C16/18 isomerized alpha olefin is not a dermal irritant based on EU classification.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to GLPs and OECD TG 404.
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