Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
3 April - 17 April 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance propane-1,2-diyl diacetate (CAS 623-84-7). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Propylene Glycol Diacetate
- Analytical purity: > 99.5%

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
Ten young adult rabbits of the New Zealand White strain (approximately 8-10 weeks old) (SPF-quality, randomly bred) were obtained from The Broekman Institute, Someren, The Netherlands. The body weights of the males on day 0 ranged from 2314 to 2544 g and those of the females from 2192 to 2386 g. Date of arrival at the animal house: March 12, 1986. The quarantine period was 7 days followed by a two-week acclimation period. The animals were housed in Lurane cages with perforated floors. The animals had free access to tap-water and were fed standard laboratory diet LK-01, pellet diameter 4 mm, 100 g per day, which was obtained from Hope Farms, Woerden, The Netherlands. The animal room temperature was maintained at 20-21°C and the relative humidity at 55-70 per cent. The artificial light sequence was 12 hours light, 12 hours dark.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
One day prior to dose application the fur from the upper dorso-lateral area of each animal was clipped to approximately 10% of the total body surface. The test substance was dosed as such and was evenly spread on a surgical gauze (9 x 13 cm) that was fixed on aluminium foil with vaseline. This patch was attached to a stroke of Durapore (3M, St. Paul, USA) which was applied to the clipped area of each animal and fixed with flexible bandage (Coban, 3M, St. Paul, USA). The dose volume was 1.890 ml/kg body weight. After 24 hours of exposure, the semi-occlusive bandage was discarded, and the remaining test substance on the treated surface was gently removed with moist tissues.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
One group of young adult New Zealand White rabbits, comprising 5 males and 5 females, received a single dermal dose of PGDA at 2000 mg/kg body
weight. No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. Weekly group mean body weight gain was normal . There was no evident sex related effect. Macroscopic examination of all animals at the end of the study revealed no test substance related abnormalities for half the animals whereas the remaining half showed petechiae in the skel eta1 muscle underlying the treated surface. Since no mortalities occurred the LD50 value for males and females combined was estimated to exceed 2000 mg/kg body weight.
Statistics:
Body weight mean and standard deviation were calculated.

Due to the response no LD50 value was formally calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: All animals survived a single 24 hour dose of 2000 mg/kg/day.
Mortality:
All animals survived dermal exposure to 2000 mg/kg bw/day.
Clinical signs:
No signs of systemic toxicity were observed during exposure and the following 14-day observation period. The treated skin surface of the animals showed slight to mild erythema upon bandage removal. Thereafter no more abnormalities were observed
Body weight:
The group mean body weight gain was normal.
Gross pathology:
Macroscopic examination of all animals at autopsy revealed no treatment related gross abnormalities for five animals whereas the remaining five
animals showed petechiae in the skeletal muscle underlying the treated surface.
Other findings:
No additional information available

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified