Registration Dossier
Registration Dossier
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EC number: 614-144-2 | CAS number: 67800-94-6
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study full in compliance with OECD Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A guideline-compliant GPMT was available from a period before the LLNA-guideline was adopted. The GPMT was considered sufficient to demonstrate the absence of a sensitizing potential of the test substance.
Test material
- Reference substance name:
- Oligomerisation products of o-Diaminotoluene with ethylene oxide and propylene oxide
- EC Number:
- 614-144-2
- Cas Number:
- 67800-94-6
- Molecular formula:
- C7 H10 N2. ( C3 H6 O )x.(C2 H4 O)y ; 1 < x + y < 8.5
- IUPAC Name:
- Oligomerisation products of o-Diaminotoluene with ethylene oxide and propylene oxide
- Details on test material:
- - Name of test material (as cited in study report): Desmophen VPPU 1907
- Physical state: liquid
- Analytical purity: content 99.9 %
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Bor : DHPW
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5% for intradermal induction
100% for topical induction
50% and 100% for first challenge
25% for second challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5% for intradermal induction
100% for topical induction
50% and 100% for first challenge
25% for second challenge
- No. of animals per dose:
- control: 10 animals/group
test substance: 20 animals/group - Details on study design:
- RANGE FINDING TESTS:
- for intradermal induction: concentrations of 0, 1, 2.5, and 5 % were tested
- for topical induction: concentrations of 0, 12, 25, 50 % and 100 % were tested
- for challenge: concentrations of 0, 12, 25, 50 and 100 % were tested
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2; first induction intradermal, second induction topical 7 days later
- Exposure period: 48 h oclcusive in the topical induction
- Test groups: 20 animals
- Control group: 10 animals
- Concentrations: 5 % for intradermal induction, 100 % for topical induction
- Because the substance was not a skin irritant in the pilot study, the test area after shaving was painted with a solution of 10% sodium lauryl sulphate before topical induction
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: challenge started 3 weeks after intradermal induction
- Exposure period: 24 hours
- Concentrations: 50 % and 100 %
- Evaluation (hr after challenge): 48 and 72 hours after start of challenge
Reliability of the test system is routinely confirmed by alpha hexyl cinnamic aldehyde among others. - Challenge controls:
- yes: control group animals were treated in challenge experiments according to test group animals
- Positive control substance(s):
- yes
- Remarks:
- Reliability of the test system is routinely confirmed by alpha hexyl cinnamic aldehyde among others.
Results and discussion
- Positive control results:
- Routinely performed tests with positive controls confirmed the reliability of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- erythema: score 1
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: erythema: score 1.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- erythema: score 1
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: erythema: score 1.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Executive summary:
Under the conditions of guinea pig maximization test according to OECD TG 406 the substance was shown to exhibit no skin sensitization potential.
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