Registration Dossier
Registration Dossier
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EC number: 205-745-7 | CAS number: 149-73-5
Endpoint summary
Administrative data
Description of key information
Skin sensitisation, guinea pig maximisation: not sensitising (Huels,
Muermann 1992)
Skin sensitisation, guinea pig: not sensitising (DuPont Haskell, Hood
1966)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-04-08 to 1992-05-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted before REACH came into force.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: Pirbright White HSD/Win:DH (SPF)
- Age at study initiation: young adult
- Weight at study initiation: 310 - 381 g
- Housing: conventional, up to 5 animals/Macrolon cage type IV
- Diet: ad libitum, Ssniff G 4 Alleindiaet fuer Meerschweinchen
- Water: communal drinking water ad libitum
- Acclimation period: > 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: 1992-04-08 To: 1992-05-08 - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Remarks:
- Maiskeimoel MEH 56
- Concentration / amount:
- Intradermal pretest: 0.25, 0.5, 1.0, 2.5, 5, 10 % w/w in corn oil
Epicutaneous pretest: 2.5, 25, 50 % w/w in corn oil, 100% undiluted liquid test article
Epicutaneous induction: 100% undiluted liquid
Intradermal induction: 10% w/w in corn oil
Epicutaneous induction: 100% undiluted liquid - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Remarks:
- Maiskeimoel MEH 56
- Concentration / amount:
- 100% undiluted liquid
- No. of animals per dose:
- Intradermal pretest: 2 animals
Epicutaneous pretest: 4 animals
Main test: 20 animals
Controls to main test: 10 animals - Details on study design:
- RANGE FINDING TESTS:
Formulation: Corn oil was found to be an appropriate vehicle, which formed homogeneous mixtures with the liquid test article
Tolerability intradermal: Injection of the test substance in corn oil (0.15 cm3 of the mixtures, 6 concentrations from 0.25 to 10 % w/w) to the shaved flanks of 2 animals. Recording of skin reactions at 24 hours after injection.
Tolerability epicutaneous: Application of the test substance in corn oil (0.1 cm3 each, 3 concentrations: 2.5, 25, and 50 % w/w, and 100% liquid test material without vehicle) to the shaved flanks of 4 animals (4 gauze patches per animal, area 2x2cm each), with occlusive dressing, for 24 hours. Recording of skin reactions after removal of the patch, and at 48 and 72 hours after the start of the application.
MAIN STUDY
A. INTRADERMAL INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period:
- Test groups: 1 group of 20 animals
- Control group:
- Site:
- Frequency of applications:
- Duration:
- Concentrations:
B. EPICUTANEOUS INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period:
- Test groups:
- Control group:
- Site:
- Frequency of applications:
- Duration:
- Concentrations:
B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge:
- Exposure period:
- Test groups:
- Control group:
- Site:
- Concentrations:
- Evaluation (hr after challenge): - Challenge controls:
- No naive control group. An FCA-treated control group (as described above) was challenged in the same was as the test group.
- Positive control substance(s):
- yes
- Remarks:
- Strain sensitivity to 1-chloro-2,4-dinitrobenzene tested in regular intervals
- Positive control results:
- Strain sensitivity to 1-chloro-2,4-dinitrobenzene tested in regular intervals, no results given in present report
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.15 cm3 of undiluted liquid test substance (100 %)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema, no edema observable
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.15 cm3 of undiluted liquid test substance (100 %)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema, no edema observable
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.15 cm3 of undiluted liquid test substance (100 %)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No erythema, no edema observable
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.15 cm3 of undiluted liquid test substance (100 %). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No erythema, no edema observable.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.15 cm3 of undiluted liquid test substance (100 %)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema, no edema observable
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.15 cm3 of undiluted liquid test substance (100 %). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No erythema, no edema observable.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No erythema, edema observable.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1966
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Study performed in 1966, probably no GLP, reasonably documented (2-page summary report), but important details missing: Type of coverage (epicutaneous), volume of injection (intradermal), type and duration of challenge. Only five animals per dose. Submitted to US Office of Toxic Substances under TSCA, 1982.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Five guinea pigs each were induced by epicutaneous (9 exposures in 3 weeks) and intradermal application (4 exposures in 4 weeks). Challenge applications followed a 2-week rest period.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted before REACH came into force.
- Species:
- guinea pig
- Strain:
- other: Albino, not otherwise specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: 5 guinea pigs
- Strain: Albino - Route:
- epicutaneous, open
- Vehicle:
- not specified
- Concentration / amount:
- Not specified
- Day(s)/duration:
- 21
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- not specified
- Concentration / amount:
- Not specified
- Day(s)/duration:
- 14
- Positive control results:
- Not enough info
- Reading:
- rechallenge
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
Referenceopen allclose all
Pretest intradermal: All concentrations of the test substance, as well as the vehicle, caused well-defined erythema and edema 24 hours after injection. Therefore the highest concentration, 10 % w/w, was chosen for the intradermal induction in the main study. Pretest epicutaneous: None of the concentrations of the test substance, including the undiluted substance itself, caused any skin irritation upon application in an occlusive patch (24 hours).
Main study, intradermal induction: The injection of Freund¿s Complete Adjuvans (FCA, diluted 1:1 with saline) caused well-defined to severe erythema and edema. 10 animals of the test group and 12 of the control groups developed necrosis. The injection of the test substance (10 % in corn oil) caused very slight erythema and edema, which developed into well-defined erythema and edema in half of the animals 24 hours after the injection. Reactions of the same grade were observed in the control animals after the injection of the vehicle corn oil. Injection of the test substance in FCA (diluted 1:1 with corn oil) caused very slight to well-defined erythema and edema, which developed into moderate edema and erythema after 24 hours; one animal developed necrosis.
Main study, epicutaneous induction: All injection sites of FCA (50% in saline, mixed with corn oil, or mixed with 10% of the test substance and corn oil) were affected by severe erythema, eschar formation, bleeding, and strong edema. Injection sites of the test substance in corn oil, or the pure vehickle in the controls, showed only scale formation.
Main study, challenge: No signs of irritation in the test and control group.
No signs of irritation observed (in pretest)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A key skin sensitisation study (guinea pig maximisation) conducted 1992 according to guideline OECD 406 and under GLP is available. The study is considered to be relevant, reliable (Klimisch 1) and adequate for the purposes of risk assessment, classification and labelling.The maximisation study elicited no positive responses in any animal. The test substance is graded as a non-sensitiser.
A supporting study (non-GLP, 1962) with epicutaneous and intradermal induction (5 animals each) confirms these findings; trimethyl orthoformate is not sensitising.
Justification for classification or non-classification
The substance is not sensitising.
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