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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

In a limited early acute oral toxicity study female rats were dosed with 5000 mg/kg bw C.I. Direct Blue 264. 2/10 animals died during the 14 days observation period, consequently the oral LD50 is above 5000 mg/kg bw.
In an acute dermal toxicity study conducted according to OECD TG 402 C.I. Direct Blue 264 is regarded as non-toxic after dermal application. The limit dose is 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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Early study conducted according to scientifically accepted method
Qualifier:
no guideline followed
Principles of method if other than guideline:
10 female Wistar rats were dosed by gavage with a single dose of C.I. Direct Blue 264. Animals were observed for 14 days and number of death and alive animals were recorded.
GLP compliance:
no
Test type:
other: Limit test
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
peanut oil
Doses:
5
No. of animals per sex per dose:
10
Control animals:
no
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Single dose of 5000 mg/kg bw was used. 2/10 animals died during the 14 day observation period.

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
In a limited early acute oral toxicity study in female rats. 2/10 animals died during the 14 days observation period, consequently the oral LD50 is above 5000 mg/kg bw.
Executive summary:

In a limited early acute oral toxicity study in female rats. 2/10 animals died during the 14 days observation period, consequently the oral LD50 is above 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
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

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
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 males and 6 females
Control animals:
not required
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg bw of C.I. Direct Blue 264 applied semiocclusively for 24 hours.

A dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities, toxicologically relevant clinical signs, toxicological effects on weight development and gross pathological findings.

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
In an acute dermal toxicity study conducted according to OECD TG 402 C.I. Direct Blue 264 is regarded as non-toxic after dermal application.
Executive summary:

Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg bw of C.I. Direct Blue 264 applied semiocclusively for 24 hours.

A dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities, toxicologically relevant clinical signs, toxicological effects on weight development and gross pathological findings.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

In a limited early acute oral toxicity study female rats were dosed with 5000 mg/kg bw C.I. Direct Blue 264. 2/10 animals died during the 14 days observation period, consequently the oral LD50 is above 5000 mg/kg bw.

In an acute dermal toxicity study conducted according to OECD TG 402 C.I. Direct Blue 264 is regarded as non-toxic after dermal application. The limit dose is 2000 mg/kg bw.

 

Justification for classification or non-classification

C.I. Direct Blue 264 is of low toxicity.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.