Triglycerides, C16-C18 (even numbered) and C18 (unsaturated), maleated

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Acceptable publication which meets basic scientific principles, but only limited data reported. As the substance is a breakdown product of the target substance, this study is considered valid for read-across.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Comparative toxicity of synthetic and natural glycerin

Author:

Hine, C.H. et al.

Year:

1953

Bibliographic source:

Arch Ind Hyg Occup Med 7:282-291, 1953 (47)

Reference 2

Reference Type:

secondary source

Title:

OECD SIDS Initial Assessment Report For SIAM 14 - Glycerol

Author:

OECD

Year:

2201

Bibliographic source:

http://www.inchem.org/documents/sids/sids/56815.pdf

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A group of 6 rabbits were dermally exposed under occlusive consitions for 8 hours with synthetic or natural glycerol in amounts of 6250 to 18700 mg/kg bw.

GLP compliance:

no

Remarks:

prior to GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol

EC Number:

200-289-5

EC Name:

Glycerol

Cas Number:

56-81-5

IUPAC Name:

glycerol

Details on test material:

Test material 1:
- Name of test material (as cited in study report): Natural glyerine, achieved from market stock
- Analytical purity: unknown
- Impurities (identity and concentrations): fatty acids and esters


Test material 2:
- Name of test material (as cited in study report): Synthetic glycerin
- Analytical purity: 99.5%
- Impurities (identity and concentrations): mainly water with very small amounts of glycerin polymers and glyceraldehyde

Test animals

Species:

rabbit

Strain:

other: "Albino"

Sex:

male

Details on test animals or test system and environmental conditions:

- Source: local suppliers
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: Metal cages bedded with sawdust housed them in approximately equal groups
- Diet (e.g. ad libitum): commercial animal food pellets of known composition, supplemented weekly with greens
- Acclimation period: quarantined for about two weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 -17

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal region of trunk
- Type of wrap if used: rubber dam

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 6250 - 18700 mg/kg bw
- Concentration (if solution): 100%

Duration of exposure:

8 h

Doses:

6250 - 18700 mg/kg bw

No. of animals per sex per dose:

6 animals in total

Control animals:

no

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 18 700 mg/kg bw

Based on:

test mat.

Remarks on result:

other: for natural and synthetic glycerine

Clinical signs:

No signs of clinical toxicity were observed for either synthetic or natural glycerol.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

No deaths were observed in a group of 6 rabbits after occlusive dermal application for 8 hours of synthetic or natural glycerol at 18700 mg/kg bw.