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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reliability is assumed to be 1 as data are taken from NONS file

Data source

Reference
Reference Type:
other: Body reponsible for the test
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): none specified, but the substance was Pigment Red 254 (EC 401-540-3; CAS 84632-65-5)
- Substance type: pigment
- Physical state: solid
- Analytical purity: -
- Other: -

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
nose only
Vehicle:
other: 10% (w/w) Sipernat 50s
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
2.25 mg/L air
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.25 mg/L air
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC0
Effect level:
2.25 mg/L air
Exp. duration:
4 h
Mortality:
Male: 2.25 mg/L; Number of animals: 5; Number of deaths: 0
Female: 2.25 mg/L; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: Inspecific symptoms, reversible after 5 to 9 days.
Gross pathology:
During the autopsy no specific damages were found.
The histopathology did not reveal any substance-related effects.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a GLP-study according to OECD test guideline 403, PR 254 was not toxic at a concentration of 2.25 mg/l air via the inhalation route. Therefore, it is considered to be not acutely toxic via the inhalation route.
Executive summary:

In a GLP-study according to OECD test guideline 403, PR 254 was not toxic at a concentration of 2.25 mg/l air via the inhalation route. Therefore, it is considered to be not acutely toxic via the inhalation route.