Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientific acceptable and well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Noakes and Sanderson (1969), Brit J Ind Med 26, 59
Principles of method if other than guideline:
Single cutan application of 2.5 ml of the test substance to 5 male and 5 female rats. post observation period was 14 days.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Baylectrol 4900, liqiud substance; density: 1.035 kg/liter (according LXS MSDS)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
male + femaleWistar rats, SPF, ca. 9 - 14 weeks old, average weight of 179 g (males) and 152 g (females), husbandry: conventional in makrolon cages typ III

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
animals were inspected several times on the same day of the application of the test substance. During the post observation period of 14 days animals were inspected twice daily (daily on weekends) and time of onset, duration, and severity of clinical signs recorded
Duration of exposure:
4 or 24 h (according Noakes and Sanderson (1969), Brit J Ind Med 26, 59)
Doses:
2.5 ml per animal
No. of animals per sex per dose:
5 male + 5 female rats
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: During the post observation period of 14 days animals were inspected twice daily and time of onset, duration, and severity of clinical signs recorded, animals were weighened before, after 1 week and at the end of the post-observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology
Statistics:
not applicable - all animals survived

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 587 mg/kg bw
Mortality:
all animals survived
Clinical signs:
no symptoms of poisoning were observed
Body weight:
no data
Gross pathology:
section of some animals killed at the end of the test showed no specific findings
Other findings:
no data

Any other information on results incl. tables

Single dermal exposure of rats to 2587 mg/kg bw: no symptoms of toxicity

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Method: according Noakes and Sanderson (1969), Brit J Ind Med 26, 59; single cutan application of 2.5 ml of the test substance to 5 male an d 5 female rats. post observation period was 14 days

Result: LD50 > 2.5 ml/kg bw (2587 mg/kg bw), (rats, male + female); no deaths, no symptoms of poisoning were observed.

reference: Kroetlinger (Bayer AG), 1984