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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Description, Identificaton and Storage:
-Sponser's Identification: ETHYL TETRAHYDROFURFURYL ETHER
-Date received: 18 Novemebr 1998
-Description: colourless liquid
-Storage conditions: room temperature in dark under nitrogen

Data relating to the identity, purity and stability of the test matyerial are the responsibilty of the Sponser.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Three New Zealand White rabbits supplied by David Percival Ltd, Moston, Sandbach, Chesire, Uk were used.
At the start of the study the animals weighed 2.81 to 3.25kg and were 12 - 16 weeks old. After a minimum acclimatisation period of five days each animal was given a number unique within a study whic was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.

Animals were individually housed in suspended metal cages. Free access to mains drinking water and food (STANRAB SQC Rabbit Diet, Special
Diets Services Ltd, Witham, Essex, Uk) was allowed throughout the study.

Animal room was maintained at a temperature of 16 to 21°C and relative humidity of 43 to 65%. On one occasion the temp. was below the limited
specified in the protocol (17°C). This deviation was considered not to affect the purpose or integrity of the study. 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.

Test system

Preparation of test site:
clipped
Amount / concentration applied:
Three suitable test sites were selected on the back of the rabbit. At each test site a quantity of 0.5ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm).
Duration of treatment / exposure:
One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application.
Observation period:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary
irritation
Number of animals:
Three

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 6d
Score:
2
Reversibility:
fully reversible within: 14 days

Any other information on results incl. tables

RESULTS

4-hour Exposure Period

Pale green-coloured dermal necrosis over approximately half the treatment site with severe haemorrhage of the dermal capillaries over the remaining half of the treatment site, both attributed a Draize score of 4 injuries in depth, were noted at the treated skin site one hour after patch removal. A hardened dark brown/black-coloured scab, undulating in appearance, and which precluded the evaluation of erythema and oedema was noted at the treated skin site at the 24, 48, 72 -hour and 6 -day observations.

Moderate oedema was noted at the treated skin site one hour after patch removal.

The reactions noted were indicative of dermal corrosion.

1-Hour Exposure Period

Severe haemorrhage of the dermal capillaries, resembling a bruise and attributed a Draize score of 4 injuries for in depth, was noted at the treated skin site one hour after patch removal. A hardened dark brown/black coloured scab, undulating in appearance, and which precluded the evaluation of erythema and oedema, was noted at the treated skin site at the 24, 48, and 72-hour and 6-day observations.

Slight oedema was noted at the treated skin site one hour after patch removal.

The reactions noted were indicative of dermal corrosion.

3-Minute Exposure Period

Very slight erythema was noted at all treated skin sites one hour after patch removal. Well-defined erythema was noted at all treated skin sites at the 24-hour observation. Well-defined erythema was noted at two treated skin sites with very slight erythema at the remaining treated skin site at the 48-hour observation. Well-defined erythema persisted at one treated skin site with very slight erythema at two treated skin sites at the 72-hour observation.

Very slight oedema was noted at one treated skin site one hour after patch removal, at all treated skin sites at the 24-hour observation, at two treated skin sites at the 48-hour observation and persisted at one treated skin site at the 7-day observation.

Slight desquamation was noted at one treated skin site at the 6-day observation. Moderate desquamation was noted at one treated skin site at the 7-day observation.

One treated skin site appeared normal at the 7-day observation and one other treated skin site appeared normal at the 14-day observation.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, ETHYL TETRAHYDROFURFURYL ETHER, produced reactions indicative of dermal corrosion and was classified as CORROSIVE to rabbit skin. The test material produced corrosive effects in 1/1 rabbit according to the EU labelling regulations and was classified as CORROSIVE to rabbit skin. The symbol "C" and risk phrase R 34 "CAUSES BURNS" are therefore required.
Executive summary:

Later tests suggest material is not corrosive to skin.