Registration Dossier
Registration Dossier
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EC number: 247-063-2 | CAS number: 25513-64-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-09-17 to 1984-10-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions: No positive control (not required by 1981 version of Test Guideline)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Test material
- Reference substance name:
- 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine
- EC Number:
- 247-063-2
- EC Name:
- 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine
- Cas Number:
- 25513-64-8
- Molecular formula:
- C9H22N2
- IUPAC Name:
- 2,2,4(or 2,4,4)-Trimethyl-1,6-hexanediamine
- Test material form:
- other: liquid
- Details on test material:
- 2,2,4(or 2,4,4)-trimethylhexamethylenediamine of Hüls AG, purity > 99.7 %
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS:
- Strain: Dunkin-Hartley (Bor: DHPW)
- Sex: female
- Source: Winkelmann, Borchen (Germany)
- Weight at study initiation: 428 g (mean)
- Controls: vehicle treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 °C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 1st application: Induction 0.1 % intracutaneous
2nd application: Induction 10 % occlusive epicutaneous
3rd application: Challenge 2 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1st application: Induction 0.1 % intracutaneous
2nd application: Induction 10 % occlusive epicutaneous
3rd application: Challenge 2 % occlusive epicutaneous
- No. of animals per dose:
- 20 females (test) / 20 females (control)
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Induction schedule: injection followed 1 week later by patch treatment for 48 hours
- Injection details: 0.1 ml each at 6 positions on shoulders:
2 x Freund's Complete Adjuvant
2 x test substance 0.1 % in aqua dest.
2 x Freund's Complete Adjuvant / 0.2 % test substance (50:50)
simultaneous and symmetrical application of each solution
controls: aqua dest. instead of test substance
- Challenge schedule: 2 weeks after end of induction patch treatment for 24 hours
- Concentrations used for challenge: 2 %; readings 24, 48, and 72 hours after removal of patch
- Rechallenge: no
- Positive control: no
EXAMINATIONS
- Grading system: possible scores 0 / 1 / 2 / 3
0 % of animals scored > 0: no sensitization
1 - 8 % of animals scored > 0: very slight sensitization
9 - 28 % of animals scored > 0: slight sensitization
29 - 64 % of animals scored > 0: distinct sensitization
65 - 80 % of animals scored > 0: severe sensitization
81 -100 % of animals scored > 0: extreme sensitization - Challenge controls:
- similarly treatment, but with vehicle alone
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- not examined
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2 %
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- see "Remarks on results"
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2 %. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: see "Remarks on results".
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no reactions.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2 %
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- see "Remarks on results"
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2 %. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: see "Remarks on results".
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no reactions
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no reactions.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 2 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- see "Remarks on results"
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 2 %. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: see "Remarks on results".
- Reading:
- other: 3 rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no reactions
- Remarks on result:
- other: Reading: other: 3 rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: Vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no reactions.
Any other information on results incl. tables
RESULTS OF TEST
- Sensitization reaction:
16/20 animals positive at 24 and 48 hours = severe sensitization
8/20 animals positive at 72 hours
no animals positive in control group
- Clinical signs:
1st induction, FCA application sites: distinct erythema and edema and slight necrosis
1st induction, FCA + test substance application sites: severe erythema and edema, necroses and brown / black discoloration
1st induction, vehicle application sites: slight erythema
2nd induction, test group: inflammation, black discoloration
2nd induction, control group: slight inflammation at few injection sites
Applicant's summary and conclusion
- Conclusions:
- In a guinea pig maximization test (according to OECD Guideline 406, positive controls not required by 1981 guideline version), sensitization was observed in 16 of 20 female animals. Based on these results, 2,2,4(or 2,4,4)-trimethylhexane-1,6 -diamine should be classified as contact sensitizer.
- Executive summary:
The skin sensitizing properties of 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine were conducted in a guinea pig maximization test according to OECD 406 (positive controls not required by 1981 guideline version). Twenty female guinea pigs were intradermally injected with a 0.1 % concentration of 2,2,4(or2,4,4)-trimethylhexane-1,6 -diamine (in water) and one week later epidermally exposed to a 10 % concentration of test substance. Twenty control animals were similary treated, but with vehicle alone. Two weeks after the epidermal application all animals were challegend with 2 % test substance and the vehicle.
Under the conditions of the test sensitizing effects were observed in 16 of the 20 animals at 24 and 48 hours. Based on these results, 2,2,4(or 2,4,4)-trimethylhexane-1,6 -diamine should be classified as contact sensitizer.
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