Formaldehyde, reaction products with diethanolamine and 6(or 7)-methyl-1H-benzotriazole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 5, 1981 - October 19, 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:

(limited documentation (test substance, gross pathology), acclimation period 4 days)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzotriazol, ar-methyl-, reaction product with formaldehyde and Diethanolamine

EC Number:

939-703-0

Cas Number:

1474044-75-1

Molecular formula:

C16H19N - C28H43N (main constituents)

IUPAC Name:

Benzotriazol, ar-methyl-, reaction product with formaldehyde and Diethanolamine

Details on test material:

- Analytical purity: no data
- Physical state: liquid

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 175 g (males) and 167 g (females)
- Fasting period before study: overnight
- Housing: groups of 5 in Macrolon cages (type 3)
- Diet: NAFAG No. 890, NAFAG, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

containing 0.5% CMC

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

500, 1000 and 2000 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: 1, 2, 3, 5 and 24 h after treatment and then daily until day 14
- Frequency of weighing: day 1, 7 and 14
- Necropsy of survivors performed: no data
- 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:

1 472 mg/kg bw

Based on:

test mat.

95% CL:

> 1 104 - < 2 298

Mortality:

- 500 mg/kg bw: 0/10
- 1000 mg/kg bw: 1/10
- 2000 mg/kg bw: 8/10

Clinical signs:

other: Sedation, dyspnoea, ruffled fur, ventral/lateral/curved body position

Gross pathology:

no data

Any other information on results incl. tables

Table 1: Table for acute oral toxicity

 

Dose [mg/kg bw]	Mortality*	Time of death	Mortality (%)
Males
500	0/5	---	0
1000	1/5	Day 1	20
2000	3/5	Day 1	60
Females
500	0/5	---	0
1000	0/5	---	0
2000	5/5	Day 1	100
LD50 = 1472 mg/kg bw

                                                                                            

* first number = number of dead animals                                   

 second number = number of animals used                             

 

Table 2: Clinical symptoms

Signs/Symptoms	Dose (mg/kg bw)
	500	1000	2000
Sedation	---	1 h – day 3	1 h – 5 h
Dyspnoea	1 h – day 9	1 h – day 9	1 h – day 9
Ruffled fur	1 h – day 8	1 h – day 8	1 h – day 8
Ventral body position	1 h	1 h	1 h – 5 h
Curved body position	1 h – day 7	1 h – day 7	1 h – 7 h
Lateral body position	---	---	1 h – 3 h

 

Table 3: Mean body weights (g)

Dose [mg/kg bw]	Day 1	Day 7	Day 14
Males
500	173	233	277
1000	175	229	273
2000	179	228	266
Females
500	164	194	214
1000	172	201	221
2000	164	---	---

 

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral LD50 of the test article in rats of both sexes observed over a period of 14 days is 1472 (1104-2298) mg/kg. The test material is therefore slightly toxic to the rat by this route of administration.