Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study performed in accordance with OECD guideline and in compliance with GLP guidelines. As the study is performed with a substance analogue, in accordance with REACH guidance the maximum reliability for read-across data is 2. Read-across is justified because of the similar chemical nature of the target substance compared to the analogues. The read-across rationale can be found in the analogue approach document attached in Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline for Testing of Chemicals no. 403, adopted 12 May, 1981.
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Physical form of substance: S
Mass median aerodynamic diameter (for liq.+solid aerosol):
particle size cumulative %

<= 0.7 9.9

<= 1.1 30.4

<= 1.9 48.5

<= 3.1 79.5

<= 5.0 91.2

<= 8.2 100

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: none used
Details on inhalation exposure:
nose only
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5.16 +/- 0.48 g/m3
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.16 mg/L air
Exp. duration:
4 h
Mortality:
Male: 5.16 mg/L; Number of animals: 5; Number of deaths: 0
Female: 5.16 mg/L; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: During exposure: Slight visually decreased breathing rate in all animals. After exposure: Cold upon touching (2M/1F) directly after exposure. Dirty fur of the head (2F) until day 7. Alopecic area
Body weight:
In general slightly reduced mean body weight gain was seen seven days after exposure.
Gross pathology:
Macroscopic:

Sparsely haired abdomen (1F).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU