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Diss Factsheets

Administrative data

Description of key information

Skin irritation (in vivo): Tyzor LA is a skin irritant as 25% in water.

Eye irritation (in vivo): Tyzor LA is a eye irritant (undiluted)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
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
Specific details on test material used for the study:
25% solution of test material in water
Species:
guinea pig
Strain:
not specified
Remarks:
albino
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
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.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test material is skin irritant as 25% in water.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Remarks:
In vitro study not performed since in vivo study available.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
In vitro study not performed since in vivo study available.
Qualifier:
no guideline followed
Principles of method if other than guideline:
One-tenth milliliter of the test material was placed into the right conjuctival sac of each of two albino rats. After 20 seconds, one treated eye was washed with tap water for one minute. The treated eye of the other rabbit was not washed. Observations of the cornea, iris and conjuctivae were made with hand-slit lamp at one and four hours, and at one, two and three days.
GLP compliance:
no
Specific details on test material used for the study:
50% solution of test item
Species:
rabbit
Strain:
not specified
Remarks:
albino
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
20 sec
Observation period (in vivo):
At one, four hours, one, two and three days
Number of animals or in vitro replicates:
2
Details on study design:
One-tenth milliliter of the undiluted test material was placed into the right conjuctival sac of each of two albino rats.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritant / corrosive response data:
Mild redness was observed after 24 and 48 h.
Slight swelling was obseved after 24 h.
Moderate purulent discharge was observed after 24 h.
No ocular effects were observed after 72 h.
Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
Tyzor LA is moderately or mildly irritating to rabbit eyes. There was no involvement of the cornea or iris and eyes were normal within 3 days.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation :

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. Mild erythema was observed in 50% of animals after 24 h and 20% of animals after 48 h exposure to test item. 

In conclusion, diammoniumdihydroxybis[lactato(2-)-O1,O2]titanate(2-), Tyzor LA is skin irritant as 25% in water.

Eye irritation:

One-tenth milliliter of the undiluted test material was placed into the right conjuctival sac of each of two albino rats. Slight to moderate ocular effects (redness, swelling, discharge) were observed after 24h and 48 h. No effects were observed after 72 h.

In conclusion, diammoniumdihydroxybis[lactato(2-)-O1,O2]titanate(2-), Tyzor LA is eye irritant.

Justification for classification or non-classification

The substance has to be classified for Skin Irrit. 2 and to Eye Irrit. according to CLP Regulation 1272/2008.