Registration Dossier

Diss Factsheets

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:
1982-10-28 to 1982-08-04
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is an acceptable and a well-documented study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Primary dermal irritation score includes scores from abraded skin. OECD TG 404 does not recommend testing on abraded skin. Also the test involved 24hr occluded exposure
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Hydrodesulfurised middle distillate (CAS# 64742-80-9)
IUPAC Name:
Hydrodesulfurised middle distillate (CAS# 64742-80-9)
Details on test material:
- Name of test material (as cited in study report): API 81-09 (CAS# 64742-80-9)
- Physical state: Clear liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Approximately 14 weeks of age
- Weight at study initiation: Average body weights reported prior to treatment was 2716 g.
- Housing: The animals were maintained in individual cages with screened floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: At least 14 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 22 degrees Celsius
- Humidity (%):38% to 55% relative humidity
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The animals were dosed with 0.5 mL per prepared area.

No vehicle was used.
Duration of treatment / exposure:
24 hours per exposure
Observation period:
24, 72 and 96 hours, 7 and 14 days.
Number of animals:
6 male rabbits
Details on study design:
TEST SITE
- Area of exposure: The back of each animal was exposed to test material
- % coverage: not reported
- Type of wrap if used: gauze patches, secured with paper tape and saran wrap were use to maintain the test material in contact with the skin. Collars were used to retrain the animals.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test areas were not washed but were wiped.
- Time after start of exposure: 24 hours


SCORING SYSTEM: Draize technique

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hour scores
Score:
1.9
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hour scores
Score:
2.25
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean erythema score for intact skin is 1.9 and the mean oedema score is 2.25.
Executive summary:

In a primary dermal irritation study, six, young adult New Zealand White rabbits, were dermally exposed to 0.5 mL of undiluted hydrodesulfurised middle distillate under occlusion (24 hour contact time) applied to one abraded area and one intact area of skin.

 

Dermal irritation was scored according to the method of Draize at 24, 72 and 96 hours, and 7 and 14 days after test material application. One animal died on day 11 (considered unrelated to treatment).

 

The mean erythema score for intact skin is 1.9 and the mean oedema score is 2.25.

This study received a Klimisch score of 2 and is classified as reliable with restriction because it is an acceptable and well documented study report.

Categories Display