Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EWG, B.3
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: rat, Sprague-Dawley Hsd:(SD)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Angeteigt mit 0,3 ml Tylose (0,5 % in Wasser) "ENGLISH" Made into a paste with 0.3 ml tylose (0.5 % in water)
Duration of exposure:
24 h

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Während der gesamten Studiendauer traten weder Todesfälle
noch sonstige Effekte auf. Bei einem weiblichen Tier war das
Körpergewicht in der ersten Woche leicht reduziert, am Ende
der Studie war das Gewicht jedoch wieder normal.

Die Körpergewichtsentwicklung der übrigen Tiere war nicht
beeinflusst.

"ENGLISH"

Neither mortalities nor other effects occurred during the
entire duration of the study. The body weight of one female
animal was slightly reduced in the first week. However, the
weight was normal again at the end of the study.

The body-weight gain of the other animals was not
influenced.
Gross pathology:
Effects on organs:
Bei der Sektion der Tiere wurden keine makroskopisch
sichtbaren Effekte festgestellt.

"ENGLISH"

No macroscopically visible effects were determined during
the necropsy of the animals.
Other findings:
Signs of toxicity (local):
Es wurde keine Reizung festgestellt.

"ENGLISH"

No irritation was determined.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU