Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 307-298-4 | CAS number: 97592-99-9
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
