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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
26 October 1982 - 10 November 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3-dihydro-5-methoxy-2H-benzimidazole-2-thione
EC Number:
253-326-2
EC Name:
1,3-dihydro-5-methoxy-2H-benzimidazole-2-thione
Cas Number:
37052-78-1
Molecular formula:
C8H8N2OS
IUPAC Name:
5-methoxy-1,3-dihydro-2H-benzimidazole-2-thione
Specific details on test material used for the study:
Assay: 97%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
On arrival at the laboratory and regularly during the acclimatisation period the rabbits were examined for signs of disability.
The animals were acclimatised to laboratory conditions for 3 weeks.

The animals were kept singly in polypropylene cages, measuring approximately 50x50 cm, each with a separate dung tray. Clean dung trays were provided-three times a week and clean cages when
considered necessary or at least every second week.
The air was changed about 15 times per hoGr via a centrally placed air intake-and two peripheral ventilators.

Target values for temperature and humidity were 17 ± 1°C and 50 ± 10%, respectively. Recorded values for temperature were within the stipulated iimits, but the relative humidity was 62 % throughout the trial.
The animal rooms were illuminated by artificial light from fluorescent tubes on a 12-hour light/dark cycle.

Each animal received approximately 150 g feed (Maintenance feed for rabbits and guinea-pigs, Ewos AB, Sweden) once daily, and also a fistful of hay, and had free access to municipal tap water for human consumption.

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Amount / concentration applied:
0.3 g mixed with 10 drops of water.
Duration of treatment / exposure:
24 h
Observation period:
Up to 48 h
Number of animals:
3
Details on study design:
The back and sides of each animal were clipped free of fur, approximately 24 hours before application of the formulations.

Each test or control formulation was applied to approximately 6 cm of the intact skin of the animal, with the help of a 2.5 cm x 2.5 cm
compress. The relevant amount the formulation was spread or dripped onto the compress.

The dressing was left in place for 24 hours. Skin reaction was recorded before the formulations are applied, and directly, 1 and 24 hours after removal of the compresses. Daily observations were subsequently continued as necessary up to 14 days after removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Time point:
24 h
Remarks on result:
other: Erythema score not specifically specified
Irritation parameter:
edema score
Time point:
24 h
Remarks on result:
other: edema score not specifically specified
Irritant / corrosive response data:
No skin reaction was seen in any animal after application of the test compound or the saline and untreated controls.
Readings were made directly, 1 hours and 24 hours after removal of the compresses, but were subsequently discontinued, due to
absence of reaction.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No signs of adverse skin reaction were seen in any animal. The test material is not a skin irritant according to this test.