Registration Dossier

Administrative data

Description of key information

1,3-Dichloro-5,5-dimethylhydantoin produces dermal sensitisation.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From June to August 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Buehler test is available.
Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CAMM, Research Lab Animals, Wayne, NJ
- Age at study initiation: 4-12 weeks
- Weight at study initiation: 300-500 grams
- Housing: individually housed in wire mesh bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light-dark cycle
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
1 % dichlorodimethylhydantoin in mineral oil
Day(s)/duration:
0 - 14 d
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
1 % dichlorodimethylhydantoin in mineral oil
Day(s)/duration:
1
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Ten guinea pigs tested with 1 % dichlorodimethylhydantoin in mineral oil and ten guinea pigs tested with 0.15 % 1-chloro-2,4-dinitrobenzene.
Details on study design:
RANGE FINDING TESTS:
Four animals were used to determinate the highest concentration of the test article that would produce a mean skin score for erythema less than 1. The test article was diluted with mineral oil to produce 50 %, 30 %, 10 % and 1 % concentrations. The highest concentration of the test article that produced a mean erythema score less than 1 was determined to be 1 %.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: the test group was composed by ten guinea pig treated with 0.5 ml of 1 % dichlorodimethylhydantoin in mineral oil
- Control group: the positive control group was composed by ten giunea pig treated with 0.5 ml of 0.15 % 1-chloro-2,4-dinitrobenzene
- Site: left flank
- Frequency of applications: once per week
- Duration: 0 - 14 d
- Concentrations: 0.5 ml of 1 % dichlorodimethylhydantoin in mineral oil

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days following the third application of induction phase
- Exposure period: 6 hour
- Test groups: the test group was composed by ten guinea pig treated with 0.5 ml of 1 % dichlorodimethylhydantoin in mineral oil
- Control group: the positive control group was composed by ten giunea pig treated with 0.5 ml of 0.15 % 1-chloro-2,4-dinitrobenzene
- Site: right flank
- Concentrations: 0.5 ml of 1 % dichlorodimethylhydantoin in mineral oil
- Evaluation (hr after challenge): 24, 48 h
Challenge controls:
The positive control group was composed by ten giunea pig treated with 0.5 ml of 0.15 % 1-chloro-2,4-dinitrobenzene. The negative control (mineral oil) was performed.
Positive control substance(s):
yes
Remarks:
0.15 % 1-chloro-2,4-dinitrobenzene
Positive control results:
The positive control material (0.15 % 1-chloro-2,4-dinitrobenzene) caused contact dermal sensitisation.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1% dichlorodimethylhydantoin in mineral oil
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
erythema
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.15% 1-chloro-2,4-dinitrobenzene
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
erythema
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1 % dichlorodimethylhydantoin in mineral oil
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
erythema
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.15 % 1-chloro-2,4-dinitrobenzene
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
erythema
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 % dichlorodimethylhydantoin in mineral oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
edema
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.15 % 1-chloro-2,4-dinitrobenzene
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
edema
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1 % dichlorodimethylhydantoin in mineral oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
edema
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.15% 1-chloro-2,4-dinitrobenzene
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
edema
Remarks on result:
no indication of skin sensitisation

All animals appeared normal and healthy, except one who appeared to have slightly damaged his right eye on day 1 of the study; by day 3, the eye appeared normal and the animal appeared healthy.

Interpretation of results:
other: Skin sensitiser according to the CLP Regulation (EC n. 1272/2008)
Conclusions:
1,3-Dichloro-5,5-dimethylhydantoin produces dermal sensitisation.
Executive summary:

1,3-Dichloro-5,5-dimethylhydantoin was tested for dermal sensitisation potential using the Buehler Test on Hartley derived albino guinea pigs. The product was found to produce contact dermal sensitisation.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification