Registration Dossier
Registration Dossier
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EC number: 203-308-5 | CAS number: 105-55-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- A new protocol and criteria for quantitative determination of sensitization potencies of chemicals by guinea pig maximization test.
- Author:
- Nakamura A, Momma, Sekiguchi H, Noda T, Yamano T, Kaniwa MA, Kojima S, Tsuda M abd Kurokawa Y.
- Year:
- 1 994
- Bibliographic source:
- Contact Dermatitis 1994 ; 31 : 72-85.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: Magnusson and Kligman J. Invest. Dermatol 1969 ; 52 : 268-276
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An old GPMT study and an old LLNA were available in the litterature before REACH registration. No new study were performed on skin sensitisation endpoint to fill the REACH dossier.
Test material
- Reference substance name:
- 1,3-diethyl-2-thiourea
- EC Number:
- 203-308-5
- EC Name:
- 1,3-diethyl-2-thiourea
- Cas Number:
- 105-55-5
- Molecular formula:
- C5H12N2S
- IUPAC Name:
- 1,3-diethyl-2-thiourea
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: olive oil
- Concentration / amount:
- 0, 20, 200, 2000, 20000 ppm
- Route:
- epicutaneous, open
- Vehicle:
- other: petrolatum
- Concentration / amount:
- 0, 250000 ppm
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone
- Concentration / amount:
- 0, 2, 20, 200, 2000 ppm
- No. of animals per dose:
- 2-10 per group
- Details on study design:
- Study protocol :
According to the method of Magnusson and Kligman (Magnusson B, Kligman AM. The identification of contact allergens by animal assay. The guinea pig maximization test. J Invest Dermatol 1969: 52: 268 -276.),a surface of 8 cm² (2x4 cm) was exposed to DETU.
Challenge : On day 22, all the animals received a topical open application of 0.1 ml of the test substance in their right flank (while their left flank received the vehicle).
- Clinical examinations: no
- Mortality: no
- Body weight: no
- Necropsy: no - Positive control substance(s):
- yes
- Remarks:
- but not concomitant
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- no induction
- No. with + reactions:
- 0
- Total no. in group:
- 7
- Clinical observations:
- No effects with a challenge of 0 - 0.2 - 2 - 20 - 200 and 2000 ppm
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction (20 ppm)
- No. with + reactions:
- 0
- Total no. in group:
- 7
- Clinical observations:
- challenge concentrations =0, 2, 20, 200 or 2000 ppm
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction (200 ppm)
- No. with + reactions:
- 0
- Total no. in group:
- 7
- Clinical observations:
- challenge concentrations =0, 2, 20, 200 or 2000 ppm
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction (2000 ppm)
- No. with + reactions:
- 0
- Total no. in group:
- 7
- Clinical observations:
- challenge concentrations =0 or 2 ppm
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction (2000 ppm)
- No. with + reactions:
- 3
- Total no. in group:
- 7
- Clinical observations:
- Challenge concentration = 20 ppm
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction (2000 ppm)
- No. with + reactions:
- 4
- Total no. in group:
- 7
- Clinical observations:
- challenge concentrations = 200 or 2000 ppm
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction (20 000 ppm)
- No. with + reactions:
- 2
- Total no. in group:
- 7
- Clinical observations:
- challenge concentrations = 2 ppm
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction (20 000 ppm)
- No. with + reactions:
- 4
- Total no. in group:
- 7
- Clinical observations:
- challenge concentrations =20 ppm
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction (20 000 ppm)
- No. with + reactions:
- 7
- Total no. in group:
- 7
- Clinical observations:
- challenge concentrations = 200 or 2000 ppm
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- No. with + reactions:
- 7
- Total no. in group:
- 7
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Below 2000 ppm no cutaneous reactions were observed after the challenge application.
In the animals induced by an injection of 2000 ppm, 3/7 of those challenged by 20 ppm, 4/7 of those challenged by 200 ppm and 4/7 of those challenged by 2000 ppm displayed a positive reaction. Mean response were respectively 0.4, 0.7 and 0.8.
In animals induced by an injection of 20000 ppm, 2/7 of those challenged by 2 ppm, 4/7 of those challenged by 20 ppm, 7/7 of those challenged by 200 ppm and 7/7 of those challenged by 2000 ppm had a positive reaction. Mean response were respectively 0.3, 0.6, 1.6 and 2.0.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- According this Guinea pigs maximalisation test, DETU is a skin sensitizer .
- Executive summary:
A guinea pigs maximalisation test was performed according to the Magnuson and Kligman method with DETU.
In induction phase, guinea pigs were exposed by intradermal injection (0, 20, 200, 2000, 20000 ppm of DETU) and by topical administration (0 or 250 000 ppm of DETU). In the challenge phase, animals were exposed by topical administration at : 0, 20, 200, 2000 or 20000 ppm of DETU.
Below 2000 ppm (induction phase) no cutaneous reactions were observed after the challenge application.
In the animals induced by an injection of 2000 ppm, 3/7 of those challenged by 20 ppm, 4/7 of those challenged by 200 ppm and 4/7 of those challenged by 2000 ppm displayed a positive reaction. Mean response were respectively 0.4, 0.7 and 0.8.
In animals induced by an injection of 20000 ppm, 2/7 of those challenged by 2 ppm, 4/7 of those challenged by 20 ppm, 7/7 of those challenged by 200 ppm and 7/7 of those challenged by 2000 ppm had a positive reaction. Mean response were respectively 0.3, 0.6, 1.6 and 2.0.According this Guinea pigs maximalisation test, DETU is a skin sensitizer .
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