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Administrative data

Description of key information

The oral LD50 value of Disperse Blue 359 in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Based on these results, Disperse Blue 359 does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).

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:
21 days
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
Deviations from the minimum level of daily mean relative humidity occurred, laboratory historical data did not indicate an effect of the deviations. Study integrity not adversely affected by the deviation.
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Specific details on test material used for the study:
Batch 135214 of Disperse Blue 359 was a dark blue powder with a purity of 99 %
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
All rats were of the Wistar strain. Test population consisted of 6 females (nulliparous and non-pregnant), each dose group consisted of 3 animals. Young adult animals were selected (approx. 8 weeks old) with a body weight variation that did not exceed ± 20% of the sex mean, animals were distinguished by ear and tail markings.
Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
doses were administered via an oral gavage using plastic feeding tubes. Test item preparations were stirred on a magnetic stirrer during dosing
Doses:
Single dose on day 1
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
The toxicity of the test item was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed.
Clinical signs:
Hunched posture and/or piloerection were noted for all animals on Day 1. Black discolouration of the faeces was noted for all animals between Days 2 and 4. This was considered to be due to the colour of the test item.
Body weight:
The mean body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of disperse Disperse Blue 359 in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
Based on these results, Disperse Blue 359 does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
Executive summary:

The oral LD50 value of Disperse Blue 359 in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Based on these results, Disperse Blue 359 does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification