Benzyltoluene

Acute Toxicity: oral

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

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

Test material information

Constituent 1

Reference substance name:

Benzyltoluene

EC Number:

248-654-8

EC Name:

Benzyltoluene

Cas Number:

27776-01-8

Molecular formula:

C14H14

IUPAC Name:

1-benzyl-2-methylbenzene; 1-benzyl-3-methylbenzene; 1-benzyl-4-methylbenzene

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 or test system 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:

other: - 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

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.