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Toxicological information

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:
1993/05/17-1993/06/08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

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:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Bor:WISW (SPF Cpb)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Harlan Winkelman GmbH, 33176 Borchen, Gartenstr. 27

- Weight at study initiation: 200-300g

- Housing: The animals were individually caged in Type 3 Makrolon cages

- Diet: Ssnif R 10 Comprehensive diet for rats (ad libitum), Ssniff Specialfoods GmbH, 59494 Soest

- Water: ad libitum

- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20°C ± 3°C

- Humidity (%): 30-70

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12h/12h


Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE

- Area of exposure: the back

- Type of wrap if used: the area was covered and an acrylic bandage used as wrap and attached to the sking with plaster strips.

REMOVAL OF TEST SUBSTANCE

- Washing (if done): with warm water

- Time after start of exposure: 24h


TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 1.85 cm3/kg


Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5/sex/group
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were observed 30 minutes, 1,2,3,4,5 and 6 hours post application and daily for the 14 hour bservation period. The animals were weighed at day 0, 7 and 14.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: All animals were subject to gross necropsy examination for any macroscopic abnormalities.
Statistics:
No statistical analysis of the results was deemed necessary.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities in response to application of the test substance at 2000mg/kg bw.
Clinical signs:
There was no evidence of systemic toxicity noted during the study period
Body weight:
All animals showed normal gains in body weight over the study period
Gross pathology:
There  were no abnormalities noted at necropsy.
Other findings:
- Other observations: The sections and macroscopic examinations of the animals revealed no evidence of compound related changes in any organs.

Any other information on results incl. tables

There were no visible changes in the application area in the 14 day exposure period. There were no mortalities in response to the exposure to the test substance.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 value of >2000 mg/kg bw was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.