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Toxicological information

Acute Toxicity: dermal

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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:
27 Aug - 04 Sept 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (Dec 2012)", 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:
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
GLP compliance:
yes (incl. certificate)
Remarks:
Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz, Hamburg, 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): neopentyl glycol dioleate
- Physical state: lightly yellowish liquid
- Analytical purity: no data
- Lot/batch No.: OE10124A
- Storage condition of test material: at room temperature, in a tightly closed container; kept away from heat, sparks, flames and direct sunlight

Test animals

Species:
rat
Strain:
other: CD / Crl: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Age at study initiation: 8 weeks
- Weight at study initiation: 217-227 g (males), 205-221 g (females)
- Fasting period before study: feeding was discontinued approx. 16 hours before administration
- Housing: during the 14-day observation period the animals were kept singly in MAKROLON cages (type III plus) with granulated textured wood bedding (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany).
- Diet: commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, Germany)
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10 Sept 2012 To: 24 Sept 2012

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 6 cm² shaved skin on the dorsal area of the trunk
- % coverage: 10
- Type of wrap if used: the test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips.

TEST MATERIAL
- Amount(s) applied: 2.2 mL/kg bw
Duration of exposure:
24 h
Doses:
2000 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 examined daily for mortality. Observations for clinical signs were performed before and immediately after substance application, and 5, 15, 30 and 60 min, as well as 3, 6 and 24 h thereafter. During the 14-day observation period, animals were observed daily. Body weights were determined prior to substance application and thereafter in weekly intervals up to the end of the study. Skin reactions (erythema and edema) were observed and scored 24, 48, 72 and 96 h after test substance application (Days 2-5) as well as on Days 8-12 during the 14-day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: skin irritation
Statistics:
Mean values and standard deviations of the body weight were calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs were observed up to the end of the 14-day observation period.
Body weight:
All animals gained the expected body weight throughout the whole experimental period.
Gross pathology:
No macroscopic findings were noted at necropsy.
Other findings:
- Other observations: no skin erythema and edema (scores 0) were observed 24, 48 and 72 h after substance application and up to the end of the 14-day observation period.

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