Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 - 24 Oct 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
LANDESANSTALT FÜR UMWELT, MESSUNGEN UND NATURSCHUTZ BADEN-WÜRTTEMBERG, Karlsruhe, Germany
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): 1,2,3-Propanetriol, homopolymer, diisooctadecanoate
- Physical state: yellowish, clear, viscous liquid
- Analytical purity: 100%
- Lot/batch No.: CD11110003
- Expiration date of the lot/batch: 2013-04-21
- Stability under test conditions: the stability of the test item under storage conditions over the study period was guaranteed by the sponsor.
- Storage condition of test material: room temperature
- Other: density: 0.961 g/mL

Test animals

Species:
rat
Strain:
other: Wistar Crl:WI (Han)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: approx. 9 weeks (males), approx. 13 weeks (females)
- Weight at study initiation: 282.6 g (males), 212.4 g (females)
- Housing: the animals were housed individually in Makrolon cages, type III with bedding H 15005-29 (Ssniff, Spezialitäten GmbH (Experimental Animal Diets Inc., Soest, Germany)) and environmental enrichment NGM E-022 (ABEDD® LAB & VET Service GmbH, Wien, Austria).
- Diet: VRF1(P) (SDS Special Diets Services, Altrip, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09 Oct 2012 To: 23 Oct 2012

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: about 40 cm² clipped skin of the dorsal and dorsolateral parts of the trunk
- % coverage: ca. 10
- Type of wrap if used: the application site was covered with a semi-occlusive dressing (4 layers of absorbent gauze; Ph. Eur. (Lohmann GmbH & Co., KG)) and stretch bandage (Fixomull® Stretch (adhesive fleece) (Beiersdorf AG)).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application site was rinsed with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.2 mL/kg bw
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for clinical signs several times on the day of administration and at least once daily thereafter each workday for the individual animals. A check for mortalities was made at least once each workday. Scoring of skin reaction according to Draize was performed 30-60 minutes after removal of the semi-occlusive dressing (after 24 h), weekly thereafter and on the last day of observation. Individual body weights were determined shortly before administration (Day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, scoring of skin reactions
Statistics:
Mean values and standard deviations of body weights were determined.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
No systemic clinical signs were observed during clinical examination.
Body weight:
The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weights of the female animals did not significantly change during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range.
Gross pathology:
No macroscopic pathologic abnormalities were noted at necropsy.
Other findings:
- Other observations: no local effects were observed in the male and female animals after administration.

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