Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-02-15 to 1989-03-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study is classified reliable with restrictions because the study authors do not appear to have made body weight determinations through the study period or reported data pertinent to clinical toxicity. The study does appear to have followed OECD guideline 404 recommendations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Not all data reported
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Oronite XS 101
- Substance type: 1-Dodecene dimer with 1-decene, hydrogenated
- Physical state: Liquid
- Composition of test material, percentage of components: Not reported, stated to be held by the sponsor
- Lot/batch No.: KWA 88-01217
- Stability under test conditions: Considered to be stable
- Storage condition of test material: Ambient temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: R and R Rabbitry, Stanwood, Washington
- Age at study initiation: 10 to 12 weeks old
- Housing: Individually in support-bar bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 33 to 51%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light


IN-LIFE DATES: From:1989-02-15 To:1989-03-01

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 millilitres to each of three intact sites



Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
six
Details on study design:
TEST SITE
- Area of exposure: Backs
- % coverage: Not reported
- Type of wrap if used: Loosely wrapped plastic film then paper towels held down by porous tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gauze pads moistened with mineral oil
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: sum of 1 hour, 24 hours and 72 hours
Score:
0.9
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0.57
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0.91
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Irritant / corrosive response data:
Slight erythema (0.3 - 1.0) was evident in the rabbits 1 hour post-exposure till the 72-hour post-exposure observation point (Table 1). There was no oedema observed in any of the six test animals through the study period. Flaky skin was observed in some animals up to day 7 but was absent by day 14 of the observation period. The average 72 hour erythema score was 0.70 while the oedema score for the same time period was 0.
Other effects:
No other effects were reported.

Any other information on results incl. tables

Table 1

Dermal Irritation Data

 

erythmea

Oedema

1 hour

1.0 (-)a

0 (-)

24 hours

0.9 (0-2)

0 (-)

48 hours

0.3 (0-2)

0 (-)

72 hours

0.6 (0-2)

0 (-)

7 days

0 (-)

0 (-)

aMean (range)

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 a Primary Irritation Index (PII) of 0.9 (calculated based on Draize scores at 1 hour, 24 hours and 72 hours), Oronite XS 101 is minimally irritating to the skin of New Zealand White rabbits.
Executive summary:

In an acute dermal irritation study, six young adult female New Zealand White rabbits were dermally exposed to 0.5 millilitres of undiluted Oronite XS 101 on 3 intact sites on the back for 4 hours. Animals then were observed for 14 days. Irritation was scored by the method of Draize.

 

Slight erythema (0.3 - 1.0) was evident 1 hour post-exposure till the 72-hour post-exposure observation point. The mean erythema for intact skin score over 72 hours (i.e., 24 to 72 hours) was 0.57; the mean erythema score for abraded skin over 72 hours was 0.91. The mean oedema score for both intact and abraded skin over 72 hours (i.e., 24 to 72 hours) was 0.0. There was no oedema observed in any of the six test animals throughout the study period. Flaky skin was observed in some animals up to day 7, but was absent by day 14. No other signs of clinical toxicity were reported. In this study, Oronite XS 101 is minimally irritating to the skin based on a Primary Irritation Index of 0.9.

 

This study received a Klimisch score of 2 and is classified as reliable with restriction because the study authors do not appear to have made body weight determinations through the study period or reported data pertinent to clinical toxicity. The study does appear to have followed OECD guideline 404recommendations.

This study will influence the DNEL.