Reaction mass of glycerol 1,3-di(acetate) and glycerol acetate and triacetin

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

1955-11-05

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only short abstract available.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1955

Materials and methods

Principles of method if other than guideline:

Skin sensitization was tested by a drop-on method in guinea pigs.

GLP compliance:

no

Type of study:

not specified

Justification for non-LLNA method:

study was done before LLNA method was first choice

Test material

Test material information

Constituent 1

Reference substance name:

Triacetin

EC Number:

203-051-9

EC Name:

Triacetin

Cas Number:

102-76-1

Molecular formula:

C9H14O6

IUPAC Name:

propane-1,2,3-triyl triacetate

Details on test material:

- Name of test material (as cited in study report): Triacetin
- Analytical purity: no data

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: epicutaneous drop on

Vehicle:

other: A:D: guinea pig fat

Induction 2

Concentration / amount:

0.1 M

Challenge

Challenge 1

Route:

other: no data

Vehicle:

other: A:D: guinea pig fat

Challenge 2

Concentration / amount:

0.1 M

No. of animals per dose:

5

Challenge controls:

Solvent controls were performed.

Positive control substance(s):

yes

Remarks:

Phenylhydrazine

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1 M Triacetin in A:D:Guinea Pig Fat

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: no indication of skin sensitisation; no detailed results on individual skin reactions available

Any other information on results incl. tables

Table 1: Results of Sensitisation Test with Triacetin in Guinea Pigs

Solution	Number of guinea pigs tested	Type of Test	Final Score
			24 h	48 h
0.1M Triacetin in A:D:Guinea Pig Fat	5	Drop-On	1.0	1.0
Solvent Control	3	Drop-On	1.2	1.0
Phenylhydrazine Control 0.1M in D:Guinea Pig Fat	3	Drop-On	3.2	3.7
Triacetin	5	Drop-On	0.5	0.1
1:1:3 A:D:Triacetin	5	Drop-On	0.4	0.1
4-Phenyl Catechol in A:D:Triacetin*	5	Drop-On	0.4*	0.5*
p-Phenyl diamine in A:D:Triacetin*	5	Drop-On	0.3*	0.2*

 Possible explanation for: A:D: = Acetin - Diacetin (no explanation reported).

*Not a good oil to use because sensitisers do not react in it (Triacetin probably inhibited the sensitising effect of the positive control substances 4-Phenyl Catechol and p-Phenyl diamine).

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information to guinea pig skin Criteria used for interpretation of results: expert judgment