Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was equivalent or similar to OECD TG 402 and there is no mention in the report on the status of compliance with the Principles of Good Laboratory Practice (GLP).
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): n-propyl propionate
- Physical state: colorless, transparent, low viscosity liquid
- Analytical purity: 100%
- Lot/batch No.: 51-535; 52-19 (15RLRX51)
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: assumed to be in-house
- Age at study initiation: young adults
- Weight at study initiation: 2.0 - 3.0 kg
- Fasting period before study: no
- Housing: assumed to be individually housed
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
New Zealand White rabbits, weighing between 2.0 and 3.0 kg, were subjected to 24 hours of contact with the test material which was retained under impervious sheeting on the clipped, intact skin of the trunk. On account of the large dose, gauze was wrapped around the trunk over the sample to prevent leakage and Vetrap Bandaging Tape was wrapped over the impervious sheeting and the animal was returned to its cage for the contact period
Duration of exposure:
24 hours
Doses:
16 ml/kg
No. of animals per sex per dose:
5 male + 5 female rabbits
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed daily and body weights recorded weekly
- Necropsy of survivors performed: yes
Statistics:
LD50's and the estimated LD50 slopes were calculated by the moving average method

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
16 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Conversion value of 14028.96 mg/kg based on density of 0.87681 g/cc at 25 °C
Mortality:
There were no mortalities noted in the animals dermally exposed to n-propyl propionate
Clinical signs:
There were no signs of systemic toxicity observed.
Body weight:
Body weight gain was noted in all the animals
Gross pathology:
Gross pathologic findings included mottled or dark red lungs. The lungs of one rabbit were light pink with dark red foci.
Other findings:
Local dermal effects included erythema, edema, necrosis, ecchymosis, fissuring, ulcerations, desquamation, alopecia and scabs.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, as the dermal LD50 of n-propyl propionate is in excess of 14000 mg/kg, hence based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for acute dermal toxicity.
Executive summary:

In this study, New Zealand White rabbits, weighing between 2.0 and 3.0 kg, were subjected to 24 hours of contact with the test material which was retained under impervious sheeting on the clipped, intact skin of the trunk. On account of the large dose, gauze was wrapped around the trunk over the sample to prevent leakage and Vetrap Bandaging Tape was wrapped over the impervious sheeting and the animal was returned to its cage for the contact period. After the contact period, excess fluid was removed to diminish ingestion. Observations for skin reaction were made at one hour, 7 days and 14 days after the contact period.

 

By the percutaneous route, none of 5 male and none of 5 female rabbits died from 16.0 ml/kg. Local dermal effects included erythema, edema, necrosis, ecchymosis, fissuring, ulcerations, desquamation, alopecia and scabs. There were no signs of systemic toxicity observed. Gross pathologic findings included mottled or dark red lungs. The lungs of one rabbit were light pink with dark red foci. Under the conditions of the study, as the dermal LD50 of n-propyl propionate is in excess of 14000 mg/kg, hence based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for acute dermal toxicity.