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Toxicological information

Skin irritation / corrosion

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Administrative data

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.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
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).

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot/batch No.: XF 958

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
No further data

Test system

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

Results and discussion

In vivo

Results
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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.