Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-08-19 - 2003-12-16
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Dept. of Health, UK
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Vehicle:
propylene glycol
Concentration:
2.5%, 5%, 10% and 30% w/v in propylene glycol
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Positive control results:
Hexylcinnamaldehyde was shown to be a skin sensitiser, confirming the validity of the protocol used for the study.
Parameter:
SI
Remarks on result:
other: Table of stimulation indices can be found in the executive summary below.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Table of DPMs can be found in the executive summary below.
Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
NaTG 98 %, pure is a skin sensitiser.
Executive summary:

A sample of NaTG 98% was assessed for its skin sensitisation potential using the mouse Local Lymph Node Assay. The assay determines the level of T lymphocyte proliferation in the lymph nodes draining the site of chemical application, by measuring the amount of radiolabelled thymidine incorporated into the dividing cells. The test substance was initially applied as 0.25%, 0.5% or 1% w/v preparations in propylene glycol. A further group was subsequently dosed with a 2.5%, 5% or 10% w/v preparations in propylene glycol.

 

Concentration of test substance (% w/v)

Number of lymph nodes assayed

Disintegrations per minute (dpm)

dpm per lymph node

Test control ratio

0 (vehicle only)

8

1910

2.39

N/A

0.25

8

2213

2.77

1.16

0.5

8

3909

4.89

2.05

1.0

8

1756

2.2

0.92

0 (vehicle only)

8

4262

5.45

N/A

2.5

8

5102

6.38

1.17

5

8

10102

12.63

2.32

10

8

29199

36.5

6.7

 

The test substance was shown to have the capacity to cause skin sensitisation when applied as a 10% w/v preparation in propylene glycol.

In conclusion, NaTG 98% is a skin sensitiser.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:
Experiences in humans confirmed the sensitizing potential of thioglycolates in general.

Migrated from Short description of key information:
NaTG 98% is a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on sufficient human data NaTG can be classified as:

DSD: R43. May cause sensitisation by skin contact.

EU-GHS: Skin Sens. 1. H317. May cause an allergic skin reaction.