Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data are given. Equivalent or similar to OECD guideline.

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:
not specified
Principles of method if other than guideline:
The study was carried out in accordance with Smyth HF et al (1962). Am Ind Hyg Ass J 23: 95-107.
In principle, the methods described in OCED guideline 403 were used.
GLP compliance:
no
Remarks:
pre-GLP study
Test type:
other: Inhalation Risk Test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
male and female rats
- Age at study initiation: young adult, no further data

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
atmosphere saturated with vapours of the test substance, no further data
No. of animals per sex per dose:
totally 6 males and 6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: before the start of the study and at the end of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Based on:
test mat.
Exp. duration:
7 h
Remarks on result:
other: No death were observed during a 7 h-inhalation period of the test animals in a saturated atmosphere at room temperature. As the saturation vapour pressure is very low (less than 0.001 Pa at 20 °C), no exact concentration estimation could be performed..
Mortality:
No mortality was observed when 12 rats were exposed for 7 hours to an atmosphere that had been saturated at 20°C with the volatile parts of the compound.
Clinical signs:
other: No clinical signs of toxicity were observed.
Body weight:
no data
Gross pathology:
No abnormal findings were reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No death were observed during a 7 h-inhalation exposure of rats to a saturated atmosphere of the test item at room temperature.
Executive summary:

In an acute inhalation toxicity study, one group of 12 rats (6/sex) was exposed for 7 h to a saturated atmosphere of D-Panthenol at 20°C. Animals then were observed for 14 days. No mortality occurred. No clinical signs of toxicity. were observed. No gross pathological findings were reported.