Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1981
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Cpb:WU; Wistar random
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: young adult
- Weight at study initiation: males: 140 - 164 g; females: 112 - 156 g
- Fasting period before study: overnight before treatment until 4 hours after teatment
- Housing: groups of five, males and females separated in stainless steel cages with grid-bottom
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1°C
- Humidity (%): 40 - 60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%(w/v)
Doses:
1493, 1793, 2150, 2580, and 3095 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After treatment, the rats were observed frequently for signs of intoxication during the first 4 post-treatment hours and thereafter at least once daily throughout a 14-day observation period. The individual body weights were determined on Day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights
Statistics:
The LD50 was calculated according to the method of C.S. Weil (Biometrics 8 (1952), 249-263)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 875 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 670 - <= 2 105
Mortality:
Deaths occurred between 6 hours and 3 days after treatment (see table 1 for details). Then the survivors recovered gradually and looked quite healthy again at the end of the observation period.
Clinical signs:
Clinical observations during the first 4 post—treatment hours revealed sluggishness, humpback behaviour, rough coats and slight diarrhoea. Later on soiled coats and signs of emaciation were observed.
Body weight:
The individual body weights of the survivors on Days 0, 7 and 14 indicated body weight gain within the expected range for this species and strain.
Gross pathology:
Macroscopic examination of the survivors at autopsy did not reveal any treatment-related gross alteration.

Any other information on results incl. tables

Table 1: Mortality and body weight

Dose

Mean body weight [g] on day

Mortality

Test solution [mL/kg bw]

Test substance [mg/kg bw]

0

7

14

0

7

14

Dead out of 5

 

 

males

females

males

females

5.97

1493

152

192

211

124

141

164

0

2

7.17

1793

161

196

222

125

-

-

0

5

8.60

2150

153

189

223

149

194

227

3

3

10.32

2580

153

-

-

129

-

-

5

5

12.38

3095

149

-

-

132

-

-

5

5

Applicant's summary and conclusion

Interpretation of results:
other: Acute Oral 4 (H302) according to Regulation (EC) No 1272/2008