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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study is classified as reliable with restrictions because, although the study was reportedly conducted according to generally accepted GLP standards and appeared to comply with OECD 404 guidelines, it was conducted under occlusive exposure conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

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): Oronite Synfluid PAO 4 cSt (I3982)
- Substance type: 1-Decene trimer and tetramer, hydrogenated
- Physical state: Liquid
- Analytical purity: Not reported
- Lot/batch No.: I3982
- Stability under test conditions: Stable at ambient temperature
- Storage condition of test material: Ambient temperature
- Other: Clear colourless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: R and R rabbitry (Stanwood, Washington)
- Age at study initiation: 11 to 13 weeks
- Weight at study initiation: Not reported
- Housing: Individual support bar-bottom cages
- Diet (e.g. ad libitum): Daily ration of Purina Certified High Fibre Rabbit Chow® #5325
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 20.3°C
- Humidity (%): 68.4 to 83.4%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 1988-06-14 To: 1988-06-28

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 millilitre
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Dorsal (Clipped skin on the back)
- % coverage: Approximately 1 square inch
- Type of wrap if used: Occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gauze soaked in mineral oil followed by dry gauze wipe
- Time after start of exposure: 4 hours

SCORING SYSTEM: Modified method of Draize et al. (1944)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 14 days
Score:
0.2
Max. score:
0.8
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Remarks:
intact skin; front and rear sites
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0.25
Irritation parameter:
erythema score
Remarks:
abraded skin; front and rear sites
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0.14
Irritation parameter:
edema score
Remarks:
intact skin; front and rear sites
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0.03
Irritation parameter:
edema score
Remarks:
abraded skin; front and rear sites
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Irritant / corrosive response data:
No irritation was observed 48 hours after removal of the test substance; however, well-defined erythema and/or slight oedema were observed in some animals after 72 hours. At day 7, reactions decreased with only one site showing slight erythema. On some treated animals, flakey patches were noted at the 72-hour and 7-day observations. There were no signs of irritation on day 14.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified under EU; not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based on the primary irritation score of 0.2, 1-decene trimer and tetramer, hydrogenated is considered to have caused minimal irritation when applied neat to the clipped skin of male New Zealand White rabbits.
Executive summary:

In a primary dermal irritation study, six young adult male New Zealand White rabbits were dermally exposed to 0.5 mL of Oronite Synfluid PAO 4cST (I3982) for 4 hours. Animals then were observed for 14 days. Irritation was scored by the modified method of Draize et al. (1944).

 

No irritation was observed 48 hours after removal of the test substance; however, well-defined erythema and/or slight oedema were observed in some animals after 72 hours. At day 7, reactions decreased with only one site showing slight erythema. On some treated animals, flakey patches were noted at the 72-hour and 7-day observations. There were no signs of irritation on day 14. The mean erythema score when averaging both the front and rear scores over 72 hours (i.e., 24 to 72 hours) for intact skin was 0.25 and 0.14 for abraded skin. The mean oedema score when averaging both the front and rear scores over 72 hours (i.e., 24 to 72 hours) for intact skin was 0.03 and 0.00 for abraded skin. In this study, Oronite Synfluid PAO 4cST (I3982) was minimally irritating to the skin based on a primary irritation score of 0.2.

 

This study received a Klimisch score of 2 and is classified as reliable with restrictions because, although the study was reportedly conducted according to generally accepted GLP standards and appeared to comply with OECD 404 guidelines, it was conducted under occlusive exposure conditions.

This study was selected as a supporting study because it performed under occlusive exposure conditions; however, this study contains relevant and useful data, allowing it to qualify as a supporting study.