Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Test performed prior to the implementation of the current acknowledged testing and GLP guidelines . The test conduct however was in principle very similar to the OECD TG 401 as adopted in 1981. Important aspects (e.g. 14 day-postobservation time) were considered.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
females only tested;
GLP compliance:
no
Remarks:
pre-dates GLP regulations
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain specifics: Wistar, SPF-Albino
- Source: Hoechst, breeding colony
- Weight at study initiation: 86 g - 118 g, mean 99 g on day 1 (treatment)
- Fasting period before study: approximately 16 hours before treatment
- Housing: plastic cages with softwood bedding
- Diet: Altromin 1324 ad libitum
- Water: tap water ad libitum


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 % suspension
Doses:
1 600 mg/kg body weight
2 000 mg/kg body weight
2 500 mg/kg body weight
3 200 mg/kg body weight
4 000 mg/kg body weight
5 000 mg/kg body weight
No. of animals per sex per dose:
10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination
Statistics:
Probit analysis

Results and discussion

Preliminary study:
No differences between males and females were determined in preliminary tests.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
3 327 mg/kg bw
Based on:
test mat.
Mortality:
Mortalities were observed at dose levels 2 500 to 5 000 mg/kg bw in the main study (see table below). Animals died within 1 hour to 3 days after administration of the test substance.
Clinical signs:
panting, disequilibrium, extensor spasms at prone position
Body weight:
Body weights of surviving animals were determined weekly during 14 days observation period.
The average increase of body weight at the end of the observation period was 5.4 % (low dose group) up to 10.4 % (high dose group)
Gross pathology:
macroscopic findings at necropsy in animals found dead: distinctly visible vessels in gastrointestinal tract
Other findings:
No other findigs

Any other information on results incl. tables

dose

[mg/kg body weight]

number of animals

mortalities

1 600

10

0

2 000

10

0

2 500

10

3

3 200

10

4

4 000

10

6

5 000

10

10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
the test item has not to be classified according to Regulation (EC) no 1272/2008
Conclusions:
Single application of 1 600, 2 000, 2 500, 3 200, 4 000 and 5 000 mg per kg bw test item respectively did cause graduated lethality to female rats during the 14 days observation period. According to the method of Linder and Weber the LD50 was calculated to be 3 327 mg/kg bw.
Executive summary:

Female rats were subjected to test acute oral toxicity. The test item was administered at doses of 1 600, 2 000, 2 500, 3 200, 4 000 and 5 000 mg/kg bw to 10 female rats respectively. During the 14 days observation period animals died at dose levels 2 500 and higher. According to the method of Linder and Weber the LD50 was calculated to be 3 327 mg/kg bw.

Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.