Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: This study was designed to test adverse effects of the thermal degredation products of the test material but not the material itself. No LC50 determined.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Thermal decomposition of test material containing an average of:
- 102 ppm hydrogen sulfide
- 56 ppm 2-butanethiol
- 7 ppm 4-methyl-2-pentanethiol

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 80 days
- Weight at study initiation: 373-411 g (males); 250-283 (females)
- Fasting period before study:
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 35 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24
- Humidity (%): 33-62
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Hazleton 27 in cubical chambers with pyramidal tops and bottoms
- Exposure chamber volume:
- Method of holding animals in test chamber:
- Source and rate of air:
- Method of conditioning air:
- System of generating particulates/aerosols:
- Method of particle size determination:
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber:


TEST ATMOSPHERE
- Brief description of analytical method used:
- Samples taken from breathing zone: yes/no


VEHICLE
- Composition of vehicle (if applicable):
- Concentration of test material in vehicle (if applicable):
- Justification of choice of vehicle:
- Lot/batch no. (if required):
- Purity:


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):


CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration:
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
240 min
Concentrations:
102 ppm hydrogen sulfide
56 ppm 2-butanethiol
7 ppm 4-methyl-2-pentanethiol
No. of animals per sex per dose:
8 male and 8 female
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing: 2, 7, and 11 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology

Results and discussion

Mortality:
None
Clinical signs:
other: Squinted or closed eyes. Labored breathing in two males.
Body weight:
No change between exposed and control
Gross pathology:
No gross pathologic changes were attributed to the exposure.

Any other information on results incl. tables

No mortality was observed during the study. During the exposure, squinted or closed eyes were observed in all exposed animals and two exposed males showed slightly labored breathing near the end of the exposure. There were no signs of toxicity observed in exposed animlas following the exposure or in control animlas throughout the study. There were no significant differences in mean body weights between exposed and control animals for either sex, 2, 7, or 11 days following the exposure.

No gross pathologic changes that could be attributed to the exposure were observed at necropsy following an 11 -day expsoure period.

Applicant's summary and conclusion

Interpretation of results:
other: Study did not evaluate substance being registered but rather thermal degradation products of substance being registered. No lethal dose or benchmark dose was established.
Remarks:
Criteria used for interpretation of results: other: This study cannot be used for classification purposes
Conclusions:
The acute toxicity of the degredation products of the test material does not appear to be substantially greater than hydrogen sulfide.
Executive summary:

The intent of the study was to measure the thermal decomposition products from phosphorodithioc acid, mixed O,O-bis(sec-butyl and 1,3 -dimethylbutyl) esters, zinc salts. Degradation results in formation of hydrogen sulfide and other gaseous products that may be of toxicological significance. The concentration of hydrogen sulfide was held at or around 100 ppm, below the minimum lethal concentration, to examine whether any unexcpected toxicity or lethality would occur from other materials.