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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:
2002-03-13 to 2002-03-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it was conducted according to GLP guidance.
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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Amodrill 1410
- Substance type: C14 alpha olefin

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ
- Age at study initiation: Young adult
- Housing: Housed singly in suspended steel caging with mesh floors
- Diet (e.g. ad libitum): Pelleted Purina rabbit chow, ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 millilitre



Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Two males and one female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0.56
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0.22
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48, & 72 hours
Score:
ca. 1.1
Max. score:
8
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
At the one hour observation following patch removal, well-defined erythema was observed at the treated sites. At the 24 hours observation, very slight oedema was also evident in one of the treated rabbits. Incidence and severity of irritation decreased over time. Corrosion data was not provided
Other effects:
All treated animals appeared active and healthy. Apart from dermal irritation, no other signs of gross toxicity, adverse pharmacologic effect or other abnormal behaviour were reported.

Any other information on results incl. tables

Following exposure to 1-tetradecene for 4 hours, well defined erythema was observed at the treated sites at the one hour observation period. At 24 hours observation one rabbit also exhibited very slight oedema. The overall incidence and severity of irritation decreased over time with the animals displaying no dermal irritation at 72 hours. The authors calculated a primary dermal irritation (PDII) index of 1.1 using the Draize skin scoring system.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified under OECD; not irritating
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
Based on a Primary Dermal Irritation Index of 1.1, the study author considered Amodrill 1410 was considered to be slightly irritating to the skin of rabbits; however, according to OECD GHS, the test material would not be considered irritating.
Executive summary:

In a primary dermal irritation study, young adult New Zealand rabbits (two males and one female) were dermally exposed to 0.5 millilitre of undiluted Amodrill 1410 for 4 hours to 6 square centimetre section of skin. Animals were then observed for 3 days. Irritation was scored by the Draize method.

All three rabbits exhibited well-defined erythema 1 hour following patch removal. Very slight oedema was evident in one rabbit 24 hours post exposure and all animals were free of dermal irritation by 72 hours post exposure. No signs of gross toxicity, adverse pharmacological effects or abnormal behaviour were reported. The mean erythema was 0.56 averaged over 72 hours (24, 48, and 72 hours); the mean oedema was 0.22 averaged over 72 hours (24, 48, and 72 hours). Based on a Primary Dermal Irritation Index of 1.1, the study author considered Amodrill 1410 was considered to be slightly irritating to the skin of rabbits; however, according to OECD GHS, the test material would not be considered irritating.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it is GLP compliant.