Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Justification for type of information:
Read across valid as the substnace tested is also titanate complex with alkylphosphate, degrading in water to form simple alcohols including 2-propanol and phosphate esters.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
other: intradermal injections and topical applications
Vehicle:
other: 5% v/v Acetone in Alembicol D for intradermal injection and as supplied for topical application.
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) 0.5% v/v in acetone containing 5% w/v alembicol D
b) Undiluted

Concentration of test material and vehicle used for each challenge:
20% and 50% v/v in acetone
Route:
other: topical applications
Vehicle:
other: 5% v/v Acetone in Alembicol D for intradermal injection and as supplied for topical application.
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) 0.5% v/v in acetone containing 5% w/v alembicol D
b) Undiluted

Concentration of test material and vehicle used for each challenge:
20% and 50% v/v in acetone
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Challenge controls:
Two weeks after induction, test and control animals were challenged topically with test substance at 50% and 20% v/v in acetone. Patches were applied for 24 hours and sites were evaluated 24, 48 and 72 hours after removal.
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Positive evidence of delayed contact hypersensitivity
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: Positive evidence of delayed contact hypersensitivity.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - localised dermal reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - localised dermal reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
8
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible).
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Oedema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: Oedema (barely perceptible).
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
20% v/v in acetone
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - localised dermal reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% v/v in acetone. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - localised dermal reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
20% v/v acetone
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% v/v acetone. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible).
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
20% v/v acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Oedema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% v/v acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Oedema (barely perceptible).
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Erythema (well defined) - dryness and sloughing of the epidermis observed
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: Erythema (well defined) - dryness and sloughing of the epidermis observed.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - localised dermal reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - localised dermal reaction.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible).
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Oedema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: Oedema (barely perceptible).
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
20% v/v in acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - localised dermal reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20% v/v in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - localised dermal reaction.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
20% v/v in acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Erythema (well defined) - dryness and sloughing of the epidermis observed
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20% v/v in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Erythema (well defined) - dryness and sloughing of the epidermis observed.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
20% v/v in acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - dryness and sloughing of the epidermis observed
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20% v/v in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - dryness and sloughing of the epidermis observed.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
20% v/v in acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Oedema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20% v/v in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Oedema (barely perceptible).
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - dryness and sloughing of the epidermis observed
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - dryness and sloughing of the epidermis observed.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% v/v in acetone
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% v/v in acetone. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible).
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% v/v in acetone
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - localised dermal reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% v/v in acetone. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - localised dermal reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
20% v/v in acetone
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - localised dermal reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20% v/v in acetone. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - localised dermal reaction.

Evidence of sensitisation of each challenge concentration:
Evidence of sensitisation was observed in 3 animals.

Interpretation of results:
GHS criteria not met
Conclusions:
The target substance is concluded to be not sensitising to skin, based on studies read across from sturctural analogue.
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:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Available existing study.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
other: intradermal injections and topical applications
Vehicle:
other: 5% v/v Acetone in Alembicol D for intradermal injection and as supplied for topical application.
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) 0.5% v/v in acetone containing 5% w/v alembicol D
b) Undiluted

Concentration of test material and vehicle used for each challenge:
20% and 50% v/v in acetone
Route:
other: topical applications
Vehicle:
other: 5% v/v Acetone in Alembicol D for intradermal injection and as supplied for topical application.
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) 0.5% v/v in acetone containing 5% w/v alembicol D
b) Undiluted

Concentration of test material and vehicle used for each challenge:
20% and 50% v/v in acetone
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Challenge controls:
Two weeks after induction, test and control animals were challenged topically with test substance at 50% and 20% v/v in acetone. Patches were applied for 24 hours and sites were evaluated 24, 48 and 72 hours after removal.
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Positive evidence of delayed contact hypersensitivity
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: Positive evidence of delayed contact hypersensitivity.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - localised dermal reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - localised dermal reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
8
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible).
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Oedema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: Oedema (barely perceptible).
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
20% v/v in acetone
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - localised dermal reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% v/v in acetone. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - localised dermal reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
20% v/v acetone
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% v/v acetone. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible).
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
20% v/v acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Oedema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% v/v acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Oedema (barely perceptible).
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Erythema (well defined) - dryness and sloughing of the epidermis observed
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: Erythema (well defined) - dryness and sloughing of the epidermis observed.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - localised dermal reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - localised dermal reaction.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible).
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Oedema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: Oedema (barely perceptible).
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
20% v/v in acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - localised dermal reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20% v/v in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - localised dermal reaction.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
20% v/v in acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Erythema (well defined) - dryness and sloughing of the epidermis observed
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20% v/v in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Erythema (well defined) - dryness and sloughing of the epidermis observed.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
20% v/v in acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - dryness and sloughing of the epidermis observed
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20% v/v in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - dryness and sloughing of the epidermis observed.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
20% v/v in acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Oedema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20% v/v in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Oedema (barely perceptible).
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
50% v/v in acetone
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - dryness and sloughing of the epidermis observed
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50% v/v in acetone. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - dryness and sloughing of the epidermis observed.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% v/v in acetone
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% v/v in acetone. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible).
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% v/v in acetone
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - localised dermal reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% v/v in acetone. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - localised dermal reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
20% v/v in acetone
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema (barely perceptible) - localised dermal reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20% v/v in acetone. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Erythema (barely perceptible) - localised dermal reaction.

Evidence of sensitisation of each challenge concentration:
Evidence of sensitisation was observed in 3 animals.

Interpretation of results:
other: not classified
Conclusions:
Vertec IA10 is not classified as a skin sensitiser. The study indicated that positive evidence of skin sensitisation was observed in 3 animals.
Executive summary:

Seaber (1986) is a skin sensitisation study following OECD guideline 406. The study is considered reliable without restriction and suitable for use for this endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The target substance is not sensitising to skin based on studies of structural analogue.