2,2-dimethyl-1,3-propanediyl dioleate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Aug - 04 Sept 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study (Draft)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz, Hamburg, Germany

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethyl-1,3-propanediyl dioleate

EC Number:

255-713-1

EC Name:

2,2-dimethyl-1,3-propanediyl dioleate

Cas Number:

42222-50-4

Molecular formula:

C41H76O4

IUPAC Name:

2,2-dimethyl-1,3-propanediyl dioleate

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 or test system 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:

other: No clinical signs were observed up to the end of the 14-day observation 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