Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is equivalent or similar to OECD guideline 403.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test compound: TPS 37
Chemical name: di-t-nonyl polysulfide
CAS no.: 68425-16-1
Source: Elf Aquitaine
Batch: no data
Total sulfur: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Remarks:
none
Duration of exposure:
4 h
Concentrations:
15.5 mg/L
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: sporadically throughout the study (days 1, 3, 7, 14)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, and histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 15.5 mg/L air
Exp. duration:
4 h
Mortality:
The overall mortality rate was determined to be 10%.
Clinical signs:
other: CLINICAL SIGNS: During exposure: From the very start of the exposure a very dense white fog settles in the chamber and limit the observation of the animals which remain huddled during the exposure. Only a reduction in the reaction to the noises from 45 m
Gross pathology:
The lungs were observed to be clear.

Any other information on results incl. tables

Mortality:

Total Mortality

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7

Day 8

Day 9

Day 10

Day 11

Day 12

Day 13

Day 14

Total %

Male

0

1

1

1

1

1

1

1

1

1

1

1

1

1

20

Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Total

0

1

1

1

1

1

1

1

1

1

1

1

1

1

10



Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The inhalation exposure for 4 hours of 10 rats to a nominal concentration of 15.5 mg/L (1082 ppm) TPS 37 induced a mortality of 10%..
Executive summary:

In an acute inhalation toxicity study, Sprague-Dawley rats (10/sex) were exposed (whole body) to aerosols of di-tert-nonyl polysulfide for 4 hours at a concentration of 15.5 mg/L. Animals were subsequently observed for a period of 14 days.

 

Clinical signs observed after removal of test animals from the chamber included wet fur and flight-like response. The muzzle of test animals appeared to be slightly irritated but animals appeared to return to normal activity within 15 minutes of being removed from the chamber. On day 1 post-exposure, closed palpebral slit, cyanosed eyes, polypnea, and bronchial obstruction were observed. One male rat died on day 2 but by day 4 all surviving animals appeared to be normal. Necroscopy indicated that lungs were clear. In the absence of other treatment-related signs of systemic toxicity, the acute inhalation LC50 was determined to be >15.5 mg/L.

 

The study received a Klimisch score of 2 and is classified as reliable with restrictions because the study follows guidelines equivalent of similar to OECD guideline 403.