Registration Dossier
Registration Dossier
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EC number: 905-459-9 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 976
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- other: Study from 1976 (no guidelines available at the time the study was performed).
- 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 substance name:
- Reaction mass of 1,3-diisopropylbenzene and 1,4-diisopropylbenzene
- EC Number:
- 905-459-9
- Molecular formula:
- C12H18
- IUPAC Name:
- Reaction mass of 1,3-diisopropylbenzene and 1,4-diisopropylbenzene
- Details on test material:
- Lot/batch No.: XF 958
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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
Resultsopen allclose all
- 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
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 3.56
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
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:
- study cannot be used for classification
- Conclusions:
- The TS was classified as severely skin irritating (24-hr exposure instead of 4-hr in the guideline).
- 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.
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