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Toxicological information

Acute Toxicity: dermal

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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:
1994-11-03 to 1994-11-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restrictions because it was GLP compliant and it was conducted according to OECD 402 guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
This substance is very similar with regard to health endpoints to the substance being registered.
- Name of test material (as cited in study report): Alkane 4
- Substance type: Poly alpha olefin (1-dodecene trimer, hydrogenated)
- Physical state: Liquid
- Analytical purity: Not reported
- Lot/batch No.: C1527-04-4
- Stability under test conditions: Not reported
- Storage condition of test material: room temperature
- Other: Clear colourless liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (U.K.) Ltd
- Age at study initiation: 10 to 14 weeks
- Weight at study initiation: Male: 211 to 242 grams; Female: 213 to 233 grams
- Fasting period before study: No
- Housing: Individual during exposure and in groups of 5 or 6 otherwise in grid bottom polypropylene cages
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1 (Special Diet Services Limited, Essex, U.K.) ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 50 to 69%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 1994-11-03 To: 1994-11-17

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Backs and flanks
- % coverage: Not reported
- Type of wrap if used: Occlusive - Surgical gauze covered with Micropore tape which was overwrapped with cling film and elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cotton wool moistened with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.46 mL/kg (2000 mg/kg)
- Constant volume or concentration used: Yes

Duration of exposure:
24 hours
Doses:
single dose of 2000 mg/kg
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical toxicity - 1, 2.5, and 4 hours post dosing and once daily thereafter for a period of 14 days; Body weight - Prior to exposure, on Days 0, 7, and 14; Dermal Irritation - 30 minutes post-exposure and on days 3, 7, 10, and 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight
Statistics:
Not conducted

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: Based on the lack of adverse systemic effects and mortality
Mortality:
There was no mortality observed in male or female rats dermally exposed to Alkane 4.
Clinical signs:
No signs of systemic toxicity were observed through the study period in male or female rats.
Body weight:
Body weight gain was observed to be normal in all male and female rats through the study period.
Gross pathology:
Necroscopy at termination revealed no significant treatment-related findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Acute dermal LD50 >2000 mg/kg Criteria used for interpretation of results: EU
Conclusions:
Based on the lack of adverse systemic effects and mortality, the acute dermal LD50 for Alkane 4 is >2000 mg/kg.
Executive summary:
In an acute dermal toxicity study, young adult Sprague-Dawley rats (5/sex) were dermally exposed to Alkane 4 (undiluted) for 24 hours to 37 cm2of clipped skin surface at a single dose of 2000 mg/kg bw. Animals then were observed for 14 days.

 

There were no clinical signs of toxicity or signs of skin irritation. Body weight appeared to be unaffected by treatment. No gross abnormalities were noted at necropsy. The acute dermal LD50 for Alkane 4 was greater than 2000 mg/kg.

 

This study received a Klimisch score of 1 and is classified as reliable without restrictions because it was GLP compliant and it was conducted according to OECD 402 guidelines.