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Toxicological information

Skin irritation / corrosion

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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:
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:
read-across source
Qualifier:
equivalent or similar 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: 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

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.

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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): 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

Test animals

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