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Key value for chemical safety assessment

Acute toxicity: via oral route

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Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Qualifier:
no guideline available
Principles of method if other than guideline:
No information on the guideline.
GLP compliance:
not specified
Remarks:
No information on the publication
Test type:
acute toxic class method
Limit test:
yes
Species:
mouse
Strain:
Swiss
Sex:
not specified
Details on test animals and environmental conditions:
Supplier: C.E.R Janvier, Laval, FranceAge: 6 weeksRats were caged singly in plastic cage and housed in fully air-conditioned rooms with temperature = 19-23°C and humidity continuosly recorded. Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hours period. Feeding: ad libitum coomercial pellet diet (A04, SAFE, Villemoisson, France)Drinking water: tap water ad libitumAcclimatization: one week
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
doubly distilled
Details on oral exposure:
The tested substance was dissolved in waterPositive control: DAB dimethylaminoazobenzene dissolved in olive oilNegative control: water and oil
Doses:
20, 200 and 1000 mg/kg bw
No. of animals per sex per dose:
7 animals per group
Control animals:
no
Details on study design:
Mice were given a double dose of tartrazine, 24 h apart and were killed 24 hours after the last dosing.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Mortality:
No mortality occurred
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Interpretation of results:
GHS criteria not met
Conclusions:
The tested item was found to be non-toxic for oral exposure with a LD50 > 1000 mg/kg bw.
Executive summary:

The acute oral toxicity test of Acid Yellow 23 in mice showed a LD50 value was > 1000 mg/kg.

Endpoint:
acute toxicity: oral
Type of information:
other: read across from similar substance
Adequacy of study:
supporting study
Study period:
2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
not specified
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Supplier: Charles River Wiga Gmbh, Sulzfelt, GermanyAge: 9-10 weeksBody weight: from 160 to 172 g femaleRats were caged singly in Makrolon cage type III and housed in fully air-conditioned rooms with temperature = 20-24°C and humidity = 20-80%. Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hours period. Feeding: VRF1(P); SDS Special Diets Services, Altrip, GermanyDrinking water: tap water ad libitumBedding: H15005-29; SSniff, Spezialitaten Gmbh (Experimental Animal Diets Inc, Soest, Germany)Enrichment: NGM E-022; ABEDD LAB&VET Service Gmbh, Wien, Austria
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
doubly distilled
Details on oral exposure:
Dose 300 mg/kg bw : 1 administrationDose 2000 mg/kg bw : 2 tests, the first with one administration and the second with two administrations
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
yes
Details on study design:
post-observation period 14 days
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred
Clinical signs:
In the test group of 2000 mg/kg bw discoloured yellow urine on hour 4 through to hour 5 after administration on 3 animals occurred.the test group of 300 mg/kg bw an impaired general state was found, gasping and piloerection on hour 1 to hour 5 after administration in 1 animal.
Body weight:
The mean body weights of the test groups increased normally throughout the study period.
Gross pathology:
No abnormalities
Interpretation of results:
GHS criteria not met
Conclusions:
The tested item was found to be non-toxic for oral exposure with a LD50 > 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of similar substance in female rats was assessed with this test following OECD 423 guidelines.
The LD50 value was > 2000 mg/kg.

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

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Expert judgement based on available information.

Additional information

Based on the information available both on tested substance and on similar substance 01, the acute oral LD50 in mice were > 2000 mg/kg. No adverse effect was seen in all the existing test and it coud be stated that Acid Yellow 23 does not give any concern for acute otral toxicity.

Justification for classification or non-classification

On the HPV program report there are the indication that in reports submitted to the World Health Organization, the acute oral LD50 in mice was reported to be 12,750 mg/kg bw [National Institute of Hygienic Sciences of Japan, 1964].
In rats, the LD50 by intraperitoneal injection was reported to be 2,000 mg/kg bw and the LD50 by intravenous injection was reported to be 1,000 mg/kg bw [Deutsche Forschungsgemeinschaft, 1957].

There is an acute oral toxicity study performed on another form of Acid Yellow 23 which does not show any effect. The LD50 was > 2000 mg/kg.

There are also subcrhonic and chronic studies and no toxic effects were observed.

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be > 2000 mg/kg bw in the chosen reference test, which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposure.