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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Department of health of the government of the United Kingdom
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
At that time, no OECD guideline on LLNA method had been published.

Test material

Constituent 1
Chemical structure
Reference substance name:
Mercaptoacetic acid, monoester with propane-1,2,3-triol
EC Number:
250-264-8
EC Name:
Mercaptoacetic acid, monoester with propane-1,2,3-triol
Cas Number:
30618-84-9
Molecular formula:
C5H10O4S
IUPAC Name:
1,3-dihydroxypropan-2-yl 2-sulfanylacetate 2,3-dihydroxypropyl 2-sulfanylacetate
Test material form:
solid - liquid: suspension
Details on test material:
- Name of test material (as cited in study report): Glyceryl Thioglycolate 80 %
- Analytical purity: 80.2 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 316 - 390 g
- Housing: Single or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 37 - 58
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
- Intradermal induction : 1% w/v of the supplied test material in distilled water
- Topical lnduction : 10% v/v of the supplied test material in distilled water
- Topical Challenge : 10% and 5% v/v of the supplied test material in distilled water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
- Intradermal induction : 1% w/v of the supplied test material in distilled water
- Topical lnduction : 10% v/v of the supplied test material in distilled water
- Topical Challenge : 10% and 5% v/v of the supplied test material in distilled water
No. of animals per dose:
Twenty test (10 male, 10 female) and ten control animals (5 male, 5 female)
Details on study design:
RANGE FINDING TESTS:
- The highest concentration that caused only mild to moderate skin irritation, and which was well tolerated systemically, was selected for the intradermal induction stage of the main study.
- The highest concentration producing only mild to moderate dermal irritation was selected for the TOPICAL induction stage of the main study.
- The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge stage of the main study.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Intradermal and topical induction
- Intradermal: 3 single Injections: a) Freund’s Complete Adjuvant plus distilled water in the ratio 1:1
b) a 1% w/v formulation of the supplied test material in distilled water
c) a 1% w/v formulation of the supplied test material in a 1:1 preparation of Freund’s Complete Adjuvant in distilled water
- Topical induction: 7 days after intradermal induction: Occlusive dressing with 10% v/v in distilled water for 48 h
- Control animals where treated in the same manner with vehicle instead of test material
- As the test material showed evidence for skin irritation, no local irritation by sodium lauryl sulphate was created.
B. CHALLENGE EXPOSURE
- Exposure period: 24 h
- Test groups: 5 and 10% v/v of the supplied test material in distilled water
- Control group: Vehicle
- Evaluation (hr after challenge): Approximately 24, 48 and 72 hours after challenge dressing removal, the degree of erythema and oedema was quantified.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 % v/v
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
erythema and oedema formation up to score of 2
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % v/v. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: erythema and oedema formation up to score of 2.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10% v/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 % v/v
No. with + reactions:
10
Total no. in group:
20
Clinical observations:
erythema and oedema formation up to score of 2, desquamation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % v/v. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: erythema and oedema formation up to score of 2, desquamation.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% v/v
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
no erythema or edema, only slight desquamation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% v/v. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: no erythema or edema, only slight desquamation.

Any other information on results incl. tables

INDIVIDUAL SKIN REACTIONS AT TEST ANIMALS AT CHALLENGE

 

24 h first reading

48 h second reading

72 h third reading

 

5 %

10%

5 %

10%

5 %

10%

Animal

Er

Oe

Other

Er

Oe

Other

Er

Oe

Other

Er

Oe

Other

Er

Oe

Other

Er

Oe

Other

1

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

*

2

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

3

1

0

-

1

0

-

0

0

-

0

0

D

0

0

-

0

0

D

4

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

5

1

1

-

2

1

-

1

0

-

0

1

-

0

0

-

1

0

D

6

1

1

-

2

1

-

1

1

-

2

1

D

0

0

D

0

0

D

7

0

0

-

0

0

-

0

0

D

0

0

D

0

0

D

0

0

D

8

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

9

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

10

1

0

-

2

1

-

0

0

-

1

1

D

0

0

D

0

0

D

11

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

1

1

-

12

1

1

-

1

1

-

1

0

-

1

1

D

0

0

D

0

0

D

13

1

1

-

1

1

-

1

0

-

1

1

-

0

0

D

0

0

D

14

0

0

-

1

1

-

0

0

-

2

1

-

0

0

-

0

0

D

15

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

16

0

0

-

0

0

-

#

#

#

#

#

#

#

#

#

#

#

#

17

1

1

-

2

2

-

1

1

D

2

2

D

0

0

D

0

0

D

18

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

19

0

0

-

0

0

-

0

0

-

1

0

-

0

0

-

0

0

-

20

1

1

-

1

1

-

1

1

D

1

0

-

0

0

D

0

0

D

Er = Erythema, Oe = Oedema, - = no other reactions noted, D = desquamation, * = no data; animal killed for humane reasons on Day 20, # = no data; animal found dead on Day 24

INDIVIDUAL SKIN REACTIONS AT CONTROL ANIMALS AT CHALLENGE

 

24 h first reading

48 h second reading

72 h third reading

 

5 %

10%

5 %

10%

5 %

10%

Animal

Er

Oe

Other

Er

Oe

Other

Er

Oe

Other

Er

Oe

Other

Er

Oe

Other

Er

Oe

Other

21

0

0

-

0

0

-

0

0

-

0

0

-

0

0

D

0

0

-

22

0

0

-

0

0

-

0

0

-

0

0

D

0

0

D

0

0

D

23

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

24

0

0

-

0

0

-

0

0

-

0

0

D

0

0

-

0

0

D

25

0

0

-

0

0

-

0

0

-

0

0

D

0

0

D

0

0

D

26

0

0

-

0

0

-

0

0

-

0

0

D

0

0

-

0

0

D

27

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

28

0

0

-

0

0

-

0

0

-

0

0

D

0

0

-

0

0

D

29

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

0

0

D

30

0

0

-

0

0

-

0

0

-

0

0

-

0

0

-

0

0

D

Er = Erythema, Oe = Oedema, - = no other reactions noted, D = desquamation,

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Remarks:
Migrated information
Conclusions:
GMT is a moderate sensitizer to guinea pig skin.