Reaction mass of Octyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate and 2-Ethylhexyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate

Endpoint summary

Description of key information

Acute toxicity: via oral route

The LD50 of TK 12871 was greater than 5,000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From March 11, 1981 to March 27, 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Principles of method if other than guideline:

Toxicity rating according to company standards
highly toxic LD50: < 50 mg/kg
toxic LD50: 50 - 300 mg/kg
moderately toxic LD50: 300 - 500 mg/kg
slightly toxic LD50: 500 - 5000 mg/kg
practically non toxic LD50: >5000 mg/kg

GLP compliance:

yes

Species:

rat

Strain:

other: Tif:RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Age at study initiation: 7 to 8 week old
- Water: ad libitum
- Acclimation period: at least 4 days
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50 ± 10%
- Photoperiod: 10-hrs light per day

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Doses:

5000 mg/kg

No. of animals per sex per dose:

For male: five
For female: five

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Signs and symptoms: The animals recovered within 7 days. All animals were submitted to a necropsy, at the end of the observation period.

Autopsies: No gross organ changes were observed.

 

Table 1. Rate of deaths

Dose mg/kg	Sex	Total Number animals in group	Total Number animals dead	Death rate percentage
5000	♂	5	0	0
5000	♀	5	0	0

Table 2. Body weights

Dose mg/kg	Body weights (g) ± Standard Deviation
	Male			Female
	Day 1	Day 7	Day 14	Day 1	Day 7	Day 14
5000	182±4.3	223±11.8	249±5.0	171±5.03	201±9.0	217±10.5

Interpretation of results:

GHS criteria not met

Conclusions:

According to company standards, TK 12871 was practically non- toxic to the rat by this route of administration. Therefore, TK 12871 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the CIBA-GEIGY Limited for 810281. A total of 5 male and 5 female Tif:RAIf (SPF) rats were orally dosed with TK 12871, at 5000 mg/kg. The animals recovered within 7 days. All animals were submitted to a necropsy, at the end of the observation period. No gross organ changes were observed. The LD50 of TK 12871 was greater than 5,000 mg/kg. Therefore, the test material is practically non- toxic to the rat by this route of administration.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: via oral route

A total of 5 male and 5 female Tif:RAIf (SPF) rats were orally dosed with TK 12871, at 5000 mg/kg. The animals recovered within 7 days. All animals were submitted to a necropsy, at the end of the observation period. No gross organ changes were observed. The LD50 of TK 12871 was greater than 5,000 mg/kg. Therefore, the test material is practically non-toxic to the rat by this route of administration.