Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, no guideline was indicated (but similar to OECD guideline 403)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIGA, Sulzfeld Germany
- Weight at study initiation: 185 + 15 g
- Diet: Food from Herilan MRH from the firma H . EGGERSMANN KG, Rinteln/Weser
- Water: Tap water ad libitum

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
A dynamic inhalation head - nose exposre system. An infusion pump (UNITA i, B. BRAUN, Melsungen) that constantly assist in supplying aerosols.

TEST ATMOSPHERE
- Brief description of analytical method used: Gaschromatographie
- Samples taken from breathing zone: yes

CLASS METHOD
- Rationale for the selection of the starting concentration: Based of an "inhalation risk test" the doses were selected aimed to include a no effect level (0 mortality).
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Nominal: 0.3, 0.104, 0.1, 0.06 mg/L
Measured (analyt.): 0.12, 0.085, 0.05, 0.035 mg/L
No. of animals per sex per dose:
10 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs and mortality were observed every day. Weighing was performed on day 7 and at the end of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology.
Statistics:
Statistics was performed according to D .J . Finney; Probitanalysis 1971, p. 1- 150.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
0.07 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
Mortality was observed at dose groups (nominal) 0.1 mg/L (mortality of male animals 7/20 and 3/20 mortality of female animals, animals died with in a period of 14 days), 0.104 mg/L (mortality of male animals 2/10 and 5/10 mortality of female animlas, animals died within a period of 14 days) , 0.3 mg/L (mortality of male animals 10/10 and 10/10 mortality of female animals, animals died within a period of 8 days).
Clinical signs:
other: Symptoms of exposure observed were clear to reddish eye and nasal discharge, changed breathing pattern, respiratory sounds, reduced movements and squatting posture, staggering and high stepping gait, and ruffled fur.
Body weight:
Body weight development of the female animals exposed to the low concentration was not influenced. Body weight development in the surviving male animals of the other groups was depressed in the first post exposure week in a concentration dependent manner, but reeovered in the second week.
Gross pathology:
During necrapsy the animals that died showed dilation of aurieles, acute general congestion, hyperemia, edema and emphysema of the lungs as well as lobular pattern in the Iiver. Partly carnified lungs were noted in some surviving animals examined at the end of the study.

Applicant's summary and conclusion