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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, other
Remarks:
an in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The work described was performed in compliance with UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1997 (SI 1997/654)). These Regulations are in accordance with GLP standards published as OECD Principles on Good Laboratory Practice (revised 1997, ENV/MC/CHEM(98)17); and are in accordance with, and implement, the requirements of Directives 87/18/EEC and 88/320/EEC.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
see below

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Description, Identification and Storage Conditions

Sponder's identification: ETHYL TETRAHYDROFURFURYL ETHER
Date received: 18 November 1998
Description: colourless liquid
Storage conditions: room temperature under nitrogen in the dark

Data relating to the identity, purity and stability of the test material are the responsibility of the sponser.

For the purpose of this study the test material was freshly prepared as follows:

Intradermal Induction: 1% w/v in distilled water, 1% w/v in a mixture of Freund's, Complete Adjuvant plus distilled in water (1:1)
Topical Induction: undiluted as supplied
Topical Challenge: undiluted as supplied and 75% v/v in distilled water.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
21 male albino Dunkin Hartley guinea pigs supplied by David Hall Limited, Burton-on-Trent, Stafforshire, UK were used. At the start of the main study the animals weighed 305 to 369g, and were approximately eight to twelve weeks old. After an acclimatisation period of at least five days, each animal was selected at random and given a unique number within the study which was written on a small area of clipped rump using a black indelible marker-pen.

The animals were housed singly or in pairs in solid-floor polypropylene cages furnished with woodflakes. Free access to mains tap water and food (Guinea Pig FD1 Diet, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.

The animal room was maintained at a temperature of 19 to 22°C and relative humidity of 44 to 54%. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
arachis oil
Concentration / amount:
Intradermal: 10% in arachis oil BP.
Topical: 50% acetone: PEG 400 (70:30)
Challenge
Route:
intradermal
Vehicle:
arachis oil
Concentration / amount:
Intradermal: 10% in arachis oil BP.
Topical: 50% acetone: PEG 400 (70:30)
No. of animals per dose:
A group of fifteen guinea pigs were used for the main study, ten test and five control. The bodyweight of each animal was recorded at the start and end of the study.
Challenge controls:
Intradermal injections were administered using an identical procedure to that used for the test animals, except that the injections were:

a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) distilled water
c) a 50% w/v formulation of distilled water in Freund's Complete Adjuvant/distilled water 1:1
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1% w/v
No. with + reactions:
21
Total no. in group:
21
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1% w/v
No. with + reactions:
9
Total no. in group:
21

Any other information on results incl. tables

Interpretation of Results

The precentage of test animals that showed a more severe reaction at the test material challenge site than the most severe reaction seen in the control animals, was compared with the following scale:

 Percentage of animals sensitised  Classification of sensitisation potential
 0 non-sensitiser 
 > 0 - 8  weak sensitiser
 > 8 - 28  mild sensitiser
 > 28 - 64  moderate sensitiser
 > 64 - 80  strong sensitiser
 > 80 - 100  extreme sensitiser

The data obtained may be used to classify the test material according to Commission Directive 93/21/EEC adapting Council Directive 67/54/EEC on the classification, packaging, and labelling of dangerous substances.

The test material will be classified as sensitising and assigned the symbol "Xi", the indication of danger 'irritant' and the risk phrase R 43 "MAY CAUSE SENSITISATION BY SKIN CONTACT" if 30% or more of the test animals show a sensitisation response.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, ETHYL TETRAHYDROFURFURYL ETHER, produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No symbol and risk phrase are required.