Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1985-08-20 to 1986-02-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD TG 402.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Four instead of 5 animals per sex used, animals not transferred to clean cages every 2 weeks, temperature ranged from 21 to 24 degrees celsius instead of 21 +/- 2 degrees Celsius
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: oily liquid
Details on test material:
- Name of test material (as cited in study report): Light Paraffinic Distillate
- Test substance: Unrefined light paraffinic distillate
- Molecular weight (if other than submission substance): 296
- Physical state: Liquid (light amber)
- CAS number: 64741-50-0
- Viscosity, cSt: 2.67 at 100°C
- API Gravity: 31.5
- Flash Point: (°F) 372
- Sulfur, Wt %: 0.2
- Nitrogen ppm: 256
- Distillation ASTM D 86 equivalent (°F) range: 601-803 (10-95%)
- Initial Boiling Point (°F): 579
- Composition of test material, Wt. %:
Olefins: 39.7
Naphthenes 21.7
- PONA % by MS: 37

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Approximately 14 weeks
- Weight at study initiation: 2561 to 3192 grams

- Housing:
- Diet (e.g. ad libitum): Ad libitum, Purina Certified Rabbit Chow F5322
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24
- Humidity (%): 56 to 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage: 10 % of total body area was shaved
- Type of wrap if used: eight-ply gauze bandage overwrapped with saran wrap and elastoplast tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg


Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed for clinical signs and mortality hourly for the first 6 hours after dosing, then daily for dermal irritation and twice daily for clinical signs and mortality for a period of 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, histopathology
Statistics:
No data reported.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Number dead/Number dosed
Females (intact): 0/2
Females (abraded): 0/2
Males (intact): 0/2
Females (abraded): 0/2
Clinical signs:
With the exception of dermal irritation, the only clinical sign observed was soft stool on study day 4 for one male and three female animals.
Body weight:
Average body weights (g)
Male (intact):
initial - 2603
day 7 - 2635
terminal - 2773
Male (abraded):
initial - 2697
day 7 - 2651
terminal - 2627
Female (intact):
initial - 2978
day 7 - 2892
terminal - 3171
Female (abraded):
initial - 3022
day 7 - 2985
terminal - 3246
Gross pathology:
Necropsy Findings: No visible lesions on 2 males and 4 females. Dry, crusty, tan material covering skin of test site on 2 males.

Any other information on results incl. tables

Acute Dermal Toxicity

Summary of Clinical Signs

(Number of Animals Affected)

 

Hours

Days

Observation

1

2

3

4

5

6

1

2

3

4

5

6

7

8

9

10

11

12

13

14

2.0 g/kg - Males

Appeared

4

4

4

4

4

4

4

4

4

3

4

4

4

4

4

4

4

4

4

4

Soft stool

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2.0 g/kg – Females

Appeared

4

4

4

4

4

4

4

4

4

1

4

4

4

4

4

4

4

4

4

4

Soft stool

0

0

0

0

0

0

0

0

0

4

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 was determined to be greater than 2000 mg/kg of body weight for both males and females.
Executive summary:

In an acute dermal toxicity study, groups of 14 week old New Zealand White rabbits (4 male/4 female) were dermally exposed to light paraffinic distillate for 24 hours to 10% of body surface area at a single dose of 2000 mg/kg bw. Animals then were observed for 14 days.

 

With the exception of dermal irritation, the only clinical sign observed was soft stool on study day 4 for one male and three female animals. Dermal irritation observed during the study ranged from slight to severe for erythema and oedema, from slight to marked for fissuring, and from slight to moderate for atonia and desquamation. Slight coriaceousness was also observed. One male animal exhibited a body weight loss at days 7 and 14 weighings. This animal had an abraded test site.  The dermal LD50 was determined to be greater than 2000 mg/kg of body weight for both males and females.

This study received a Klimisch score of 1 and is classified as reliable without restrictions because it was conducted according to or similar to guideline study OECD TG 402.