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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliance and test procedure in accordance with national standard methods (AFNOR norm) with few deviations but no restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: AFNOR T03-021
Deviations:
yes
Remarks:
The age of animals at study initiation was not reported; individual results (bodyweight, clinical signs) were not reported.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Ugilec 101
- Physical state: colourless liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: not reported
- Weight at study initiation:
Males: 189 g (mean)
Females: 157 g (mean)
- Fasting period before study: yes, animals without food from 17 to 22 hours before treatment
- Housing: 5/polycarbonate cage (40.8 cm x 33.3 cm x 15 cm)
- Diet: rodent diet ad libitum
- Water (e.g. ad libitum): ad libitum in 500- or 800-mL feeding bottle
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 50 +/- 20
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES:
The experiments started on April 27, 1981. The sacrifice date of the animals was not reported.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DOSE VOLUME APPLIED:
From 1 to 10 mL/kg

Doses:
0, 2913, 3010, 3107 and 3399 mg/kg administered as 0, 3, 3.1, 3.2, 3.5 mL/kg
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation; weighing on days 0, 6 and 14
- Necropsy of survivors performed: yes
Statistics:
Derivation of the DL50 using Litchfield and Wilcoxon method.

Results and discussion

Preliminary study:
10 animals/dose level were administered 1, 5 and 10 mL/kg (equivalent to approximately 971, 4855 and 9710 mg/kg, respectively).
At 1 mL/kg, no animal died, whereas at 5 and 10 mL/kg, all animals died.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 015 mg/kg bw
95% CL:
2 962 - 3 068
Mortality:
Mortality was observed at all tested levels, from 1/10 animals at the first dose level to 10/10 animals at the highest dose level. See table 1 in the field "Remark on results including tables and figures" for further details.
Clinical signs:
- At the 2913 mg/kg dose level, animals exhibited a slight sedation, 2 to 3 hours after the test substance administration. On day 1, they were prostrated with mid-shut eyes. No additional symptoms were noticed from day 2 and thereafter.
- At the 3010 and 3107 mg/kg dose levels, sedation, prostration and palpebral ptosis were observed one hour after administration. It persisted for approximately 30 hours. From day 2, no others findings were noted.
- At the 3399 mg/kg dose level, a deep sedation and a prostration preceded death.
Body weight:
Body weight gain was normal and no differences were noted between treated and control groups.
Gross pathology:
No abnormalitites were revealed at necropsy.

Any other information on results incl. tables

Table 1 Mortality results

Treatment

Cumulated Mortality

J0 (1 h)

J0 (3 h)

J1

J4

J7

J14

Males

Vehicle

0

0

0

0

0

0

TS at 2913 mg/kg bw

0

0

1

1

1

1

TS at 3010 mg/kg bw

0

0

1

2

2

2

TS at 3107 mg/kg bw

0

0

4

5

5

5

TS at 3399 mg/kg bw

0

0

5

5

5

5

Females

Vehicle

0

0

0

0

0

0

TS at 2913 mg/kg bw

0

0

0

0

0

0

TS at 3010 mg/kg bw

0

0

3

4

4

4

TS at 3107 mg/kg bw

0

0

2

2

2

2

TS at 3399 mg/kg bw

0

0

5

5

5

5

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 value for the substance was calculated to be 3015 mg/kg in both sexes with a confidence interval (p<0.05) of 2962-3068 mg/kg.
Executive summary:

The possible acute oral toxicity of BENZYL TOLUENES was evaluated in Sprague-Dawley rats according to the AFNOR guideline #T03-021401 and GLP. In this study, groups of 5 Sprague-Dawley rats/sex/dose were given the substance at 0 to 3.5 mL/kg by gavage. The mortality and general behavior of the animals were observed  for a period of 14 days after the administration. The mortality rate was 10%, 60%, 70% and 100% at the dose levels of 3, 3.1, 3.2, 3.5 ml/kg, respectively. Prostration and sedation were observed after treatment. The bodyweight of the animals were not influenced by the treatment. The LD50 was found to be 3.105 ml/kg bw, equivalent to 3015 (2962-3068 mg/kg) mg/kg bw, based on the density of the substance of 0.971 mL/g.