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Description of key information

A valid acute oral and acute dermal toxicity study are available 

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:
other: GLP conform guideline study
Qualifier:
according to
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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.

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

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

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.

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
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:
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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

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.

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
2 000 mg/kg bw

Additional information

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.

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.