1,4-bis[(2-ethyl-6-methylphenyl)amino]anthraquinone

Endpoint summary

Description of key information

A valid acute oral and acute dermal toxicity study are available: 

OECD 401 - Acute Oral toxicity / GLP / K / Rel.1
OECD 402 - Acute Dermal toxicity / GLP / K / Rel.1

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Five male and five female Wister rats (average weight at the beginning of the study 197 and 174 g, respectively ) received per gavage a single dose of 5000 mg/kg bw Macrolex Blau CA 51056. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed on animals killed after the observation period.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Doses:

5000 mg/kg bw (m + f)

No. of animals per sex per dose:

5 male and five female animals per dose

Control animals:

no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Clinical signs:

other: other:

A dose of 5000 mg/kg bw was tolerated without symptoms.

Interpretation of results:

GHS criteria not met

Executive summary:

Five male and five female Wistar rats (average weight at the beginning of the study 197 and 174 g, respectively ) received per gavage a single dose of 5000 mg/kg bw Macrolex Blau CA 51056. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed on animals killed after the observation period.

A dose of 5000 mg/kg bw was tolerated without symptoms. The LD50 is > 5000 mg/kg bw for male and female rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg body weight of the test item applied semioclclusively for 24 hours.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: RCCHan:WIST

Sex:

male/female

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female rats per dose

Control animals:

not required

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died.

Clinical signs:

other: A dose of 2000 mg/kg body weight was tolerated by males and females without toxicologically relevant clinical signs.

Gross pathology:

The necropsies performed at the end of the study revealed no particular findings.

Clinical Signs

A dose of 2000 mg/kg body weight was tolerated by males and females without toxicologically relevant clinical signs. Locally, a blue discoloration of the treatment area was observed.

The most plausible interpretation is a discoloration by the blue color of the test item (which is not considered a toxicologically relevant effect).

Body Weights

There were no toxicologically significant effects on body weight or body weight development in males and females.

Gross Pathology Findings

The necropsies performed at the end of the study revealed no particular findings.

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 2000 mg/kg bw (discriminating dose)

Executive summary:

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg body weight of the test item applied semioclclusively for 24 hours.

None of the animals died. A dose of 2000 mg/kg body weight was tolerated by males and females without toxicologically relevant clinical signs. There were no toxicologically significant effects on body weight or body weight development in males and females.

The necropsies performed at the end of the study revealed no particular findings.

LD50 > 2000 mg/kg bw (rat, male + female)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Oral Acute toxicity

Five male and five female Wister rats received per gavage a single dose of 5000 mg/kg bw Macrolex Blau CA 51056. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed on animals killed after the observation period. A dose of 5000 mg/kg bw was tolerated without symptoms. The LD50 is > 5000 mg/kg bw for male and female rats.

 

Dermal Acute toxicity

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg body weight of the test item applied semioclclusively for 24 hours. None of the animals died. A dose of 2000 mg/kg body weight was tolerated by males and females without toxicologically relevant clinical signs. The necropsies performed at the end of the study revealed no particular findings.

LD50 > 2000 mg/kg bw (rat, male + female)

Justification for selection of acute toxicity – oral endpoint
key study used

Justification for selection of acute toxicity – dermal endpoint
key study used

Justification for classification or non-classification

Due to the results of the acute oral and acute dermal study a classification is not justified in accordance with CLP Regulation No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.