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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 - 22 October 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydantoin
EC Number:
207-313-3
EC Name:
Hydantoin
Cas Number:
461-72-3
Molecular formula:
C3H4N2O2
IUPAC Name:
hydantoin
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England
- Age at study initiation: three and a half month old
- Weight at study initiation: 2.87-2.98 kg
- Housing: individually housed in suspended stainless steel cages mounted in mobile batteries (Modular Systems and Development Company Limited, London, England)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C (range 15-23°C)
- Humidity (%): 55% R.H. (range 40%-70% R.H.)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 19 October 1992 To: 22 October 1992

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 x 6 cm
- Type of wrap if used: unmedicated gauze patch (3 x 2 cm), held in place by strips of waterproof plaster

REMOVAL OF TEST SUBSTANCE
- Washing: warm water and dried with paper towels to remove excess test material adhering to the skin
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after removal of the bandages

SCORING SYSTEM:
- Method of calculation: criteria of Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No dermal response was observed at the test site of any animal at any time during the 72 hour observation period.
The control sites did not show any response to the control procedure.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The potential of Hydantoin to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of the test material to the closely-clipped dorsa of three New Zealand White rabbits for four hours. No dermal response was observed at the test site of any animal at any time during the 72 hour observation period. Under the criteria of GHS, Hydantoin was classified a non-irritant to the skin.