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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (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 (OECD 429)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 99.3%

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: 8 – 12 weeks
- Weight at study initiation: 17.0 g – 21.0 g
- Housing: single housed


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24°C
- Humidity (%): 30 – 70%
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
60% (w/w); maximum technically applicable concentration
No. of animals per dose:
5

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Value:
0.98

Any other information on results incl. tables

Treatment

Cell Count

Stimulation

Index1

Cell Count

Stimulation

Index HC2

³H-thymidine

incorporation

Stimulation Index1

³H-thymidine

incorporation

Stimulation Index HC2

Lymph Node

Weight

Stimulation Index

Ear Weight

Stimulation

Index

vehicle propylene glycol

1.00

 

1.00

 

1.00

1.00

60% in propylene glycol

0.98

1.24

0.90

2.22

1.05

1.00

 

1Stimulation Index (SI) calculated using the concurrent vehicle group

2Stimulation Index (SI) calculated using the historical control (HC) data for the vehicle propylene glycol

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Neopentylglycol does not show a skin sensitizing effect in the Murine Local Lymph Node Assay under the test conditions chosen.