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Diss Factsheets

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Internal BASF method was used which was in large part equivalent to OECD guideline 403
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3,5-trimethylhydroquinone
EC Number:
211-838-3
EC Name:
2,3,5-trimethylhydroquinone
Cas Number:
700-13-0
Molecular formula:
C9H12O2
IUPAC Name:
2,3,5-trimethylbenzene-1,4-diol
Details on test material:
- Name of test material (as cited in study report): 2,3,5-trimethylhydroquinone
- Substance No.: 77/749
- Substance type: yellow powder
- Analytical purity: 99.5%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: MUS RATTUS, Brunnthal, Germany
- Weight at study initiation: mean 185 g (male), 183 g (female)
- Diet (e.g. ad libitum): Herilan MRH, H . EGGERSMANN KG, Rinteln/Weser, Germany, ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
other: ethanol / Lutrol E 400 (1:1)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- System of generating particulates/aerosols: Zweistoffdüse (Rhema ), Infu 362 Infusionspumpe (Datex)
- Temperature, humidity, pressure in air chamber: ca. 1.5 Pa


TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography in DMF; sample was taken with 2 connected Impinger bottles. Amount was up to 30 l with 3 l/min
- Samples taken from breathing zone: yes


VEHICLE
- Composition of vehicle (if applicable): Ethanol p.a. and Lutrol E 400 1:1
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gas chromatography
Duration of exposure:
4 h
Concentrations:

Group 5,4,3,2,1:
analytical concentration: 0.64, 0.87, 1.38, 1.73, 1.96 mg/l
nominal concentration: 1.70, 2.48, 6.26, 9.17, 9.17 mg/l
No. of animals per sex per dose:
20
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to study; days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Statistics:
Probit analysis according to D .J . Finney (Probitanalysis 1971, Seite 1 - 150). Published by the Syndics of the Cambridge University Press, Bentley House, 200 Euston Road, London

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
1.5 mg/L air
Exp. duration:
4 h
Remarks on result:
other: aerosol
Sex:
male
Dose descriptor:
LC50
Effect level:
1.2 mg/L air
Exp. duration:
4 h
Remarks on result:
other: aerosol
Sex:
female
Dose descriptor:
LC50
Effect level:
1.7 mg/L air
Exp. duration:
4 h
Remarks on result:
other: aerosol
Mortality:
1.96 mg/l: 9/10 males; 8/10 females
1.73 mg/l: 8/10 males, 6/10 females
1.38 mg/l: 8/10 males, 1/10 females
0.87 mg/l: 1/10 males, 0/10 females
0.64 mg/l: 0/10 males, 0/10 females
Deaths occurred within 2 days after dosing
Clinical signs:
other: 1.38, 1.73, 1.96 mg/l: attempts to escape, eyelid closure, secretion out of eyes and nose, dyspnea, reduced pain reflex, squatting posture, spastic gait, corneal opacity, swollen snout, ruffled fur with substance adhesions. 0.87 mg/l: attempts to escap
Body weight:
Body weight gain was clearly retarded in males of groups 2 and 3 and in females of group 1 at 7 days after exposure. Animals had gained weight at 14 days; however, only body weights of the group-1 females had become similar to control values. Slight retardation of body weight gain was also seen for males of the groups 1 and 4. Body weight gain of males and females of the groups 2, 3, 4, and 5 were not significantly different from control
Gross pathology:
changes of the heart (acute vestibular dilatation, acute congestive hyperemia) and lungs (slight to moderate pulmonary emphysema) in decedents; no pathological findings in survivors.

Any other information on results incl. tables

Body weight:

dose mean body weight (g)  
prior to study day 7 day 14  
mg/l male female male female male female  Group
1.96 187 185 220 185 258 211 1
1.73 192 182 201 199 250 215  2
1.38 175 185 188 202 246 222  3
0.87 178 178 212 198 256 217  4
0.64 185 183 229 202 279 220  5
0 191 185 235 204 279 215  control

Applicant's summary and conclusion