Reaction mass of glycerol, glycerol 1-formate, glycerol 2-formate, glycerol 1,2-diformate, glycerol 1,3-diformate and glycerol triformate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

This endpoint study record is part of a Weight of Evidence approach comprising of six QSAR model predictions and a read-across from three analogue source substance studies. The results of the QSAR and the read-across studies agree as to the skin sensitisation potential and are sufficient to fulfil the information requirements as further explained in the provided skin sensitisation endpoint summary.

Data source

Reference

Reference Type:

publication

Title:

Comparative toxicity of synthetic and natural glycerin

Author:

Hine CH, Anderson HH, Moon HD, Dunlap MK, Morse MS

Year:

1953

Bibliographic source:

Arch Ind Hyg Occup Med 7:282-291

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

pre-guideline study similar to the Buehler test

GLP compliance:

no

Type of study:

Buehler test

Justification for non-LLNA method:

Pre-guideline study

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol

EC Number:

200-289-5

EC Name:

Glycerol

Cas Number:

56-81-5

Molecular formula:

C3H8O3

IUPAC Name:

Propane-1,2,3-triol

Details on test material:

GLYCERINE USP grade

Specific details on test material used for the study:

Reported as: Glycerin

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

male

Details on test animals and environmental conditions:

Adult white male guinea pigs (350 to 429 grams)

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

other: isotonic sodium chloride

Concentration / amount:

0.1 mL injections of 0.1% solutions

Day(s)/duration:

10 injections on alternate days

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

intradermal

Vehicle:

other: isotonic sodium chloride solution

Concentration / amount:

0.05 mL injection of 0.1% solution

Day(s)/duration:

2 weeks after last induction injection

Adequacy of challenge:

not specified

No. of animals per dose:

12

Details on study design:

Twelve adult white male guinea pigs were given 0.1 mL injections of 0.1% solution of glycerin in isotonic sodium chloride solution. Ten injections were made on alternate days. Two weeks after the last injection, test injections of 0.05 mL were made in the blank below the sensitizing area, using freshly prepared solutions. Twenty-four hours later, the diameter, height, and colour of the reactions were noted and compared with readings made after the first sensitizing injection.

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

rechallenge

Hours after challenge:

24

Group:

test chemical

Dose level:

0.05 mL of a 0.1% solution

No. with + reactions:

0

Total no. in group:

12

Clinical observations:

no response to the challenging injection, except a barely perceptible papule at the site

Remarks on result:

no indication of skin sensitisation

Results 2

Group:

negative control

Remarks on result:

not measured/tested

Results 3

Group:

positive control

Remarks on result:

not measured/tested

Any other information on results incl. tables

There was no response to the challenging injection, except a barely perceptible papule at the site. This would be classified as both colourless and negative on Landsteiner's scale.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The skin sensitisation potential of SS1 was assessed in a study where adult white male guinea pigs (12/group) were injected with 0.1 mL of a 0.1% solution of SS1 in isotonic sodium chloride solution. A total of 10 injections were administered on alternate days. After a 2-week resting period, animals were challenged with 0.05 mL injection of the test substance and skin reactions were observed in 24 hours. No responses to the challenging injection were noted, except a barely perceptible papule at the site, which was classified as both colourless and negative on Landsteiner’s scale.