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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

Constituent 1
Chemical structure
Reference substance name:
Heptanoic anhydride
EC Number:
210-940-5
EC Name:
Heptanoic anhydride
Cas Number:
626-27-7
Molecular formula:
C14H26O3
IUPAC Name:
heptanoic anhydride
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:
No compound-related clinical findings were observed in any of the animals.
Body weight:
The comparison of the individual data revealed a slight decrease in body weight in three male animals and in one female animal on day 7 of the test. This effect was reversible at the end of the observation period.
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.

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