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

Acute Toxicity: oral

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:

comparable to guideline study with acceptable restrictions

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

Test material information

Constituent 1

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

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: PP 126/1

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

Key result

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:

other: 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

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:

GHS criteria not met

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.