2-octyldodecyl 12-[(1-oxooctadecyl)oxy]octadecanoate

Acute Toxicity: dermal

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Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 - 26 Feb 1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The test substance was applied using an occlusive dressing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

occlusive dressing

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

yes

Remarks:

occlusive dressing

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

other: Wistar Crl:(WI)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 292 ± 13 g (mean ± SD, males); 199 ± 9 (mean ± SD, females)
- Fasting period before study: no
- Housing: animls were individually housed in labelled polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, the Netherlands)
- Diet: standard pelleted laboratory animal diet (Carfil Quality BVBA, Oud-Turnhout, Belgium), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 12 Feb 1998 To: 26 Feb 1998

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: the test substance was applied to an area of approximately 25 cm² for males and 18 cm² for females, using a gauze patch measuring 5x 5 cm and 3.5 x 5 cm, respectively
- % coverage: approximately 10% of total body surface
- Type of wrap if used: the gauze patch was fixed to aluminium foil and held in place with Coban elastic bandage (with drops of petrolatum). A piece of Micropore tape was used for additional fixation of the dressings in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed using a tissue moistened with tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (10 mL/kg bw)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed twice daily for mortality; clinical signs were observed at periodic intervals during the dosing day and once daily for the rest of the study period; the body weight was measured on Day 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes, the animals were examined for macroscopic abnormalities

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during the study period (see Table 1).

Clinical signs:

other: Red staining of the neck fur (score 1 of 3) was observed in 1/5 females on Day 8-13. This is an effect that is frequently seen in rats under stressful conditions and is therefore not considered to be toxicologically relevant. No other clinical signs were

Gross pathology:

The necropsy and histopathological examination did not revealed any substance-related findings.

Any other information on results incl. tables

Table 1: mortality and clinical signs

Dose [mg/kg bw]	Toxicological results*	Duration of clinical signs	Time of death	Mortality (%)
Males
2000	0/0/5	-	-	0
Females
2000	0/1/5	Day 8-13	-	0
Overall LD50 > 2000 mg/kg bw

* first number = number of dead animals                                 

 second number = number of animals with systemic clinical signs         

 third number = number of animals used                               

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified