Registration Dossier

Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Remarks:
other: review including information on repeat-dose (subacute) inhalation toxicity
Type of information:
other: Information on major hydrolysis product of the registered substance (released rapidly on contact with water/moisture).
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Authoritative expert review of HF exposure and toxicity.

Data source

Reference
Reference Type:
secondary source
Title:
EU Risk assessment Report, Hydrogen Fluoride CAS-No. 7664-39-3 EINECS-No. 231-634-8
Author:
The Netherlands VROM, with SZW and VWS
Year:
2001
Bibliographic source:
European Commission JRC 1st Priority List Volume:8

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
Deviations:
yes
Remarks:
Restricted list of tissues examined
Principles of method if other than guideline:
Report of a Russian inhalation toxicity study
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: inhaled test atmosphere

Test animals

Species:
rat
Sex:
female
Details on test animals and environmental conditions:
Groups of differently-aged rats were exposed to HF.

Administration / exposure

Route of administration:
inhalation
Details on inhalation exposure:
6h/day for 1 month
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
1 month
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
1 mg/cu.m
Basis:
no data
Control animals:
yes

Examinations

Sacrifice and pathology:
Expected fluoride target sites only examined:
- dental enamel
- bones
- respiratory system.

Results and discussion

Results of examinations

Details on results:
Damage to dental enamel recorded: especially notable in young animals, which also showed atrophy of respiratory organs/tissues with local oedema of bronchial mucosa.
Older animals showed peribronchial hyperplasia.
Animals around 1 year in age showed cavity formation in their bones.

Effect levels

Dose descriptor:
NOAEL
Remarks:
Single test concentration
Effect level:
1 mg/m³ air
Based on:
test mat.
Remarks:
HF
Sex:
female
Basis for effect level:
other: see 'Remark'
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Exposure to HF by inhalation at 1 mg/cu.m over a 1-month period caused evident toxicity at the expected target sites.