Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate

Endpoint summary

Description of key information

In an acute oral study five male and 5 female rats received a single dose of 10000 mg Termoplastrot Lm/400 (35% suspension in Carboxymethyl cellulose)/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days. A histopathological examination was performed at the end of the study. No mortalities occurred. Discriminating dose = 10000 mg/kg bw.

In an acute inhalation toxicity study twelve rats (male and female) were exposed to a dust atmosphere of Thermoplastrot Lm 74/400 for 8 hours at a concentration of 2.35 mg/L. After one week the animals were killed and dissected. No deaths occurred. Discriminating dose = 2.35 mg/L.

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:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

Five male and 5 female rats received a single dose of 10000 mg Termoplast Lm/400 (35% suspension in Carboxymethyl cellulose)/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days. A histopathological examination was performed at the end of the study.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Test material name given in the report: Thermoplastrot Lm 74/400

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

other: Carboxymethylcellulose 0.5% in water

Doses:

10000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female rats/dose

Control animals:

no

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

10 000 mg/kg bw

Based on:

test mat.

Mortality:

No feaths

Clinical signs:

other: Faeces were coloured dark red

Gross pathology:

No abnormalities detected

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 10000 mg/kg bw (discriminating dose).

Executive summary:

Five male and 5 female rats received a single dose of 10000 mg Termoplast Lm/400 (35% suspension in Carboxymethyl cellulose)/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days. A histopopathological examination was performed at the end of the study. No mortalities occurred. Discriminating dose = 10000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

10 000 mg/kg bw

Quality of whole database:

Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

Twelve rats (male and female) were exposed to a dust atmosphere of Thermoplastrot Lm 74/400 for 8 hours at a concentration of 2.35 mg/L. After one week the animals were killed and dissected.

GLP compliance:

no

Test type:

concentration x time method

Limit test:

yes

Specific details on test material used for the study:

Test material name given in the report: Thermoplastrot Lm 74/400

Species:

rat

Sex:

male/female

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

For saturation respective enrichement air was conducted to a layer of 5 cm thickness into the exposure chamber.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

8 h

Concentrations:

2.35 mg/liter

No. of animals per sex per dose:

12 animals (m+f)/dose

Control animals:

yes

Details on study design:

For saturation respective enrichement air was conducted to a layer of 5 cm thickness into the exposure chamber.

Sex:

male/female

Dose descriptor:

discriminating conc.

Effect level:

2.35 mg/L air

Based on:

test mat.

Exp. duration:

8 h

Mortality:

No deaths occurred.

Gross pathology:

No abnormalities detected

Interpretation of results:

GHS criteria not met

Conclusions:

No deaths occurred. Discriminating dose = 2.35 mg/L.

Executive summary:

Twelve rats (male and female) were exposed to a dust atmosphere of Thermoplastrot Lm 74/400 for 8 hours at a concenteration of 2.35 mg/L. After one week the aminals were killed and dissected. No deaths occurred. Discriminating dose = 2.35 mg/L.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

2 350 mg/m³ air

Quality of whole database:

Study well documented, meets generally accepted scientific principles, acceptable for assessment

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In a further acute study five male and 5 female mice each, received a single i.p. dose of 2150, 3160, 4640, 6810 or 10000 mg Termoplastrot Lm/400 (35% suspension in Carboxymethyl cellulose)/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days. A histopathological examination was performed. LD50 = ca. 6800 mg/kg bw (mice, m+f).

Justification for classification or non-classification

In an acute oral toxicity study in rats a discriminating dose of 10000 mg/kg bw was found. In an acute inhalation toxicity study in rats the discriminating dose was 2.35 mg/L. A acute intraperitoneal study in mice revealed a LD50 of ca. 6800 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.