Isohexadecyl 12-[(1-oxooctadecyl)oxy]octadecanoate

Acute Toxicity: dermal

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:

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 noted in any animals during the study period.

Body weight:

The body weight gains were within the normal ranges in males and females during the whole study period.

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.