Heptanoic anhydride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Aug 2002 to Feb 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Heptanoic anhydride

EC Number:

210-940-5

EC Name:

Heptanoic anhydride

Cas Number:

626-27-7

Molecular formula:

C14H26O3

IUPAC Name:

heptanoyl heptanoate

Constituent 2

Reference substance name:

Heptanoic acid anhydride

IUPAC Name:

Heptanoic acid anhydride

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Tierzucht Schönwalde GmbH, Schönwalde, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 276-313 g (males), 188-193 g (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23°C
- Humidity (%): 54-62 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

- Administration volume: 0.59 -0.67 mL / male animal or 0.40 -0.42 mL / female animal

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of clinical observation: 4 times on day 1 and thereafter once daily until day 14
- Frequency of weighing: day 1, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

none

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:

No animal died in the course of the study.

Clinical signs:

other: No compound-related clinical findings were observed in any of the animals.

Gross pathology:

Autopsy revealed no compound-related findings.

Applicant's summary and conclusion

Executive summary:

A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings and gross pathological findings. A transient slight decrease in body weight in three male animals and in one female animal on day 7 of the test was observed. This effect was reversible at the end of the observation period. According to OECD TG 402 the dermal LD50 of ZK 56406 is therefore > 2000 mg/kg body weight.