Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 14, 1981 - May 18, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (incomplete characterization of test substance, e.g. no data on substance purity), no GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(acclimation period)
Principles of method if other than guideline:
Animals fasted overnight were treated orally, with a single dose, by means of a stomach tube. Physical condition and rate of deaths were monitored throughout the whole 14 days observation period.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1H-Benzotriazole-1-methanamine, N,N-bis(2-ethylhexyl)-6-methyl- and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-5-methyl- and N,N-bis(2-ethylhexyl)-4-methyl-1H-benzotriazole-1-methylamine and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-4-methyl- and N,N-bis(2-ethylhexyl)-5-methyl-1H-benzotriazole-1-methylamine
EC Number:
939-700-4
Molecular formula:
Unspecified
IUPAC Name:
Reaction mass of 1H-Benzotriazole-1-methanamine, N,N-bis(2-ethylhexyl)-6-methyl- and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-5-methyl- and N,N-bis(2-ethylhexyl)-4-methyl-1H-benzotriazole-1-methylamine and 2H-Benzotriazole-2-methanamine, N,N-bis(2-ethylhexyl)-4-methyl- and N,N-bis(2-ethylhexyl)-5-methyl-1H-benzotriazole-1-methylamine
Details on test material:
- Analytical purity: no data
- Physical appearance: liquid

Test animals

Species:
rat
Strain:
other: RAIf (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 171.6 g - 195.8 g
- Fasting period before study: overnight
- Housing: housed in groups of 5 in Macrolon cages (type 3), marked individually with picric acid
- Diet: NAFAG No. 890, NAFAG, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 20
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water containing 0.5 % carboxymethylcellulose + 0.1 % Tween 80
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
1000, 2500, 5000 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: daily
- Frequency of weighing: day 1, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
The LD50, including the 95 % confidence limits were calculated by the logit model.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 313 mg/kg bw
95% CL:
> 2 405 - < 5 333
Mortality:
- 2500 mg/kg bw: 1/5 females and 0/5 males died (24 h after treatment)
- 5000 mg/kg bw: 5/5 females died (1 h (1), 24 h (1) and 4 d (3) after treatment) and 4/5 males died (3 h (1), 24 h (2) 4 d (1) after treatment)
Clinical signs:
Exophthalmos, dyspnoea, ruffled fur and curved body position which are unspecific signs of toxicity in acute oral study mostly occurred transient. All surviving animals recovered latest on day 8.
Sedation, diarrhoea and ventral body position was only seen in the first 5 h after treatment. Tremor was only seen on day 1 in dose group 2500 mg/kg bw.
Body weight:
Body weight changes were within the normal range.
Gross pathology:
No compound related gross organ changes were observed.

Any other information on results incl. tables

Mean body weights (g):

Dose (mg/kg bw)

Males

Females

Day 1

Day 7

Day 14

Day 1

Day 7

Day 14

1000

180

227

268

164

187

205

2500

178

204

243

159

154

190

5000

190

-

-

162

-

-

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
The acute oral LD50 of the test material in rats of both sexes observed over a period of 14 days is 3313 (2405-5333) mg/kg.