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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
In vitro study not performed since in vivo study available.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 15 1978-December 15 1978
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 irritation test was conducted on ten unexposed guinea pigs by applying and lightly rubbing in 0.05 ml of a 25% solution of test material in water on shaved and intact shoulder skin. Reactions on skin were investigated after 24 h and 48 h.
GLP compliance:
no

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% solution of test material in water

Test animals

Species:
guinea pig
Strain:
not specified
Remarks:
albino

Test system

Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.05 ml of 25% test material
Duration of treatment / exposure:
24 h and 48 h
Number of animals:
10

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal: #10
Time point:
24/48 h
Score:
0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
edema score
Basis:
animal: #9
Time point:
24/48 h
Score:
0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
edema score
Basis:
animal: #8
Time point:
24/48 h
Score:
0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
edema score
Basis:
animal: #7
Time point:
24/48 h
Score:
0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48 h
Score:
0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48 h
Score:
0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48 h
Score:
0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48 h
Score:
0
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
erythema score
Basis:
animal: #10
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
erythema score
Basis:
animal: #9
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
erythema score
Basis:
animal: #8
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
erythema score
Basis:
animal: #7
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Remarks:
Observations were recorded only at 24h and 48h timepoints.
Irritant / corrosive response data:
Mild erythema was observed in 50% of animals after 24 and 20% of animals after 48 h exposure to test item.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test material is skin irritant as 25% in water.