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Administrative data

Description of key information

NOAEL oral rat > 5000 mg/kg

NOAEL dermal mouse = not determined

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no 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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
A Method for Determining the Dermal Taxicity of Pesticides; Brit.Journ.Ind.Med. 26, 59, 1969
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
initial body weight: 150g males, 130g females
source: SPF Zucht, Wiga
Type of coverage:
not specified
Vehicle:
water
Remarks:
50%
Details on dermal exposure:
50cm2, at the back
Duration of exposure:
not described
Doses:
2500 mg/kgbw
No. of animals per sex per dose:
5
Details on study design:
post-observation period 14 days
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
no
Gross pathology:
no findings
Other findings:
remaining orange material at the applicaion site
Interpretation of results:
GHS criteria not met
Conclusions:
The tested item was found to be non-toxic for dermal exposure with a LD50 > 2500 mg/kg bw.
Executive summary:

The acute oral toxicity of Acid Orange 7 in rats of both sexes was assessed with this test following OECD 402 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

Additional information

Based on the test results, Acid Orange 7 can be considered to have the following results:

No Adverse Effect level for acute toxicity oral, LD50 > 5000 mg/kg

No Adverse Effect level for dermal toxicity but the value of LD50 > 2000 mg/kg.

Justification for selection of acute toxicity – oral endpoint

OECD 401

Justification for selection of acute toxicity – inhalation endpoint

waiving

Justification for selection of acute toxicity – dermal endpoint

OECD 402

Justification for classification or non-classification

Substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1 of CLP Regulation (EC n. 1272/2008).

Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

No classification for acute toxicity oral and acute dermal is warranted under CLP Regulation (EC n. 1272/2008).