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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
In vitro study not performed since in vivo study available.
Type of information:
experimental study
Remarks:
In vitro study not performed since in vivo study available.
Adequacy of study:
key study
Study period:
1978-10-15-1978-12-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Justification for type of information:
In vitro study not performed since in vivo study available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The primary irritation test was conducted on ten unexposed guinea pigs by applying and lightly rubbing in 0.05 mlof a 25% solution of the test material in water on shaved intact shoulder skin.
The induction phase for sensitisation was a series of four sacral intradermal injections of 0.1 ml of a 1.0% solution in physiological saline, one each week, beginning two days after the test for primary irritation.
After a 13-day rest period, the test animals were challenged for sensitization by applying and lightly rubbing in 0.05 ml of a 25% solution of test material in water on shaved, intact shoulder skin. At the same time ten unexposed guinea pigs (controls) received indentical topical applications.
GLP compliance:
not specified
Type of study:
open epicutaneous test
Justification for non-LLNA method:
In vitro study not performed since in vivo study available.

Test material

1
Chemical structure
Reference substance name:
Diammonium dihydroxybis[lactato(2-)-O1,O2]titanate(2-)
EC Number:
265-409-0
EC Name:
Diammonium dihydroxybis[lactato(2-)-O1,O2]titanate(2-)
Cas Number:
65104-06-5
Molecular formula:
C6H18N2O8Ti
IUPAC Name:
Diammonium dihydroxybis[lactato(2-)-O1,O2]titanate(2-)
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
25% test material in water

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Remarks:
albino
Sex:
male

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1 ml of 1% solution
Day(s)/duration:
A week
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
Route:
epicutaneous, open
Vehicle:
water
Concentration / amount:
0.05 ml of and 2.5% and 25% test material
Adequacy of challenge:
not specified
No. of animals per dose:
Ten
Details on study design:
The starting point was the information that the test item is moderately skin irritating at 25% solution. The primary irritation was performed at 25% solution of test item on shaved intact shoulder skin. The induction phase for sensitization was a series of four sacral intradermal injections of 0.1ml of a 1.0% solution in physiological saline, one each week, beginning two days after the test for primary irritation. After a 13-day rest period, the test animals were challenged for sensitization by applying and lightly rubbing in 0.05 ml of 25% test material in water on shaved, intact shoulder skin. At the same time ten unexposed guinea pigs (controls) received topical applications.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Group:
test chemical
Dose level:
0.05 ml 25% test item
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
other: Primary irritation
Remarks:
after 24 h
Key result
Reading:
1st reading
Group:
test chemical
Dose level:
0.05 ml of 25% tet item
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Primary irritation test
Remarks:
after 48 h
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.05 ml of 25% test material
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Mild erythema observed in 2 animals
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.05 ml of 25% test item
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Mild erythema observed in one animal
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.05 ml of 25% test item
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Mild erythema observed in three animals
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.05 ml of 25% test item
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Mild erythema observed in two animals
Key result
Reading:
other:
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No sensitization observed.