N-[3-(trimethoxysilyl)propyl-1,3-Benzenedimethanamine

Endpoint summary

Description of key information

Based on an acute oral study in rats conducted to the now deleted OECD TG 401 (Safepharm Laboratories Ltd., 1999) and in compliance with GLP, the LD50 for the submission substance was greater than 2000 mg/kg bw.

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:

22/06/1999 to 15/07/1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK.
- Age at study initiation: 8-12 weeks old.
- Weight at study initiation: Males: 207-236 g; females: 210-230 g.
- Fasting period before study: Overnight.
- Housing: Groups of five by sex in solid floor polypropylene cages furnished with wood flakes.
- Diet (e.g. ad libitum): Ad libitum, except during fasting period and 3-4 hours after dosing.
- Water (e.g. ad libitum): Ad libitum, except during fasting period and 3-4 hours after dosing.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): Approximately 15/hour
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.86 ml/kg

Doses:

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 and weighing: Animals were observed for death or overt toxicity 0.5, 1, 2 and 4 hours after dosing and then once daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: Individual body weights were recorded prior to dosing on Day 0 and on Days 7 and 14.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths or adverse effects.

Mortality:

No deaths occurred.

Clinical signs:

other: There were no clinical signs of toxicity.

Gross pathology:

No abnormal findings.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on an acute oral study in rats conducted to the now deleted OECD TG 401 (reliability score 1) and in compliance with GLP there were no deaths at a dose of 2000 mg/kg bw. The authors concluded the LD50 to be >2000 mg/kg bw. There were no adverse clinical signs, effects on body weight gain or abnormal findings during necropsy examinations.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

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

In the oral acute toxicity study (Safepharm Laboratories Ltd., 1999) in which a single limit dose of 2000 mg/kg bw of the submission substance was tested in Sprague-Dawley rats, there were no deaths, adverse clinical signs, effects on body weight gain or abnormal findings during necropsy examinations during a 14-day observation period following exposure. The LD₅₀ was >2000 mg/kg bw.

Justification for classification or non-classification

Based on the available acute oral toxicity study in rats, the submission substance is not classified for acute toxicity under Regulation (EC) No. 1272/2008.