Registration Dossier

Administrative data

Description of key information

Not corrosive and not irritating to the skin

[Weight of evidence – RL2 ; non GLP compliant ; no guideline]

Not irritating to the eyes

[Weight of evidence - RI=2 ; non GLP compliant ; no guideline]

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older study: meets scientific standards with acceptable restrictions (e.g. partly limited documentation). Exposure 24h /4h.
Qualifier:
no guideline followed
Guideline:
other: Study from 1976 (no guidelines available at the time the study was performed).
Deviations:
not applicable
Principles of method if other than guideline:
Draize test: 6 New Zealand Albino rabbits were dosed with 0.5 mL of undiluted TS over 24 hrs.
GLP compliance:
no
Remarks:
Study from 1976 (GLP was not compulsory at the time the study was performed).
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
No further data
Type of coverage:
other:
Preparation of test site:
other: intact / abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL of undiluted TS
Duration of treatment / exposure:
24 hrs
Observation period:
168 hrs
Number of animals:
6
Details on study design:
No further data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 72 hrs average
Score:
6.5
Max. score:
8
Reversibility:
fully reversible within: 168 hrs

Erythema (I / A)

Oedema (I / A)

Hours

4

24

48

72

168

4

24

48

72

168

Animal No.

1

2/2

3/4

3/4

3/3

0/0

2/2

3/4

2/3

1/2

0/0

2

2/2

4/4

4/4

4/4

0/0

2/2

4/4

3/3

3/3

0/0

3

2/2

4/4

4/4

4/4

0/0

2/2

4/4

3/3

2/2

0/0

4

2/2

4/4

4/4

3/3

0/0

2/2

4/4

3/3

2/2

0/0

5

2/2

4/4

4/4

3/4

0/0

2/2

4/4

3/3

2/3

0/0

6

2/2

3/3

3/3

3/3

0/0

2/2

3/3

2/2

2/2

0/0

I = intact; A = abraded

Defatting effect: skin sloughed off in 10 - 14 days. No injury in depth.

Interpretation of results:
other: non irritant with supporting data
Conclusions:
The TS was classified as severely skin irritating.
Executive summary:

In this older study (Draize test), 6 New Zealand Albino rabbits were dosed with 0.5 mL of undiluted TS over 24 hrs to intact or abraded skin. The irritation score (24, 72 hrs average) was given with 6.5 and the effects were fully reversible within 168 hrs. The TS was in fine not classified as skin irritating in 4h.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older study: meets scientific standards with acceptable restrictions (e.g. partly limited documentation)
Qualifier:
no guideline followed
Guideline:
other: Study from 1976 (no guidelines available at the time the study was performed).
Deviations:
not applicable
Principles of method if other than guideline:
Draize test: 6 New Zealand Albino rabbits were dosed with 0.1 mL of undiluted TS over 24 hrs.
GLP compliance:
no
Remarks:
Study from 1976 (GLP was not compulsory at the time the study was performed).
Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or tissues and environmental conditions:
No further data
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 mL of undiluted TS
Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
168 hrs
Number of animals or in vitro replicates:
6
Details on study design:
No further data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
3.2
Max. score:
110
Reversibility:
fully reversible within: 72 hrs

Hours

1

24

48

72

120

168

Mean score (X/110)

10.3

6.6

3.0

0.0

0.0

0.0

Irritation score (24, 48, 72 hrs average): 3.2

Immediate: slight discomfort

10 min: slight to moderate erythema, copious discharge

1 h: slight to moderate erythema, very slight oedema, copious discharge

24 hrs: slight erythema, moderate to copious discharge

48 hrs: gradual improvement

72 hrs: all scored zero

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
The TS was classified as slightly eye irritating.
Executive summary:

In this older study (Draize test), 6 New Zealand Albino rabbits were dosed with 0.1 mL of undiluted TS over 24 hrs. The irritation score (24, 48, 72 hrs average) was given with 3.2 and the effects were fully reversible within 72 hrs. The TS was classified as slightly eye irritating.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:

This study give detailed data on 24h exposure of rabbit skin ( normal and abraded) with effects, which are completed with the supporting skin irritation study  and the mild eye irritation to conclude of non skin irritation of DIPB as weight of evidence.

Justification for selection of eye irritation endpoint:

detailed data. Completed with supporting results for weight of evidence.

Justification for classification or non-classification

These studies give detailed data on 24h exposure of rabbit skin (normal and abrated) with effects, which are completed with the supporting skin irritation study and the mild eye irritation to conclude of non skin and eye irritation of DIPB