Registration Dossier

Toxicological information

Skin irritation / corrosion

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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:
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:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals 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:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.