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EC number: 221-967-7 | CAS number: 3296-90-0
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well conducted study, non GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. Federal Register, §191.11, 1964
- Principles of method if other than guideline:
- No further details
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2-bis(bromomethyl)propane-1,3-diol
- EC Number:
- 221-967-7
- EC Name:
- 2,2-bis(bromomethyl)propane-1,3-diol
- Cas Number:
- 3296-90-0
- Molecular formula:
- C5H10Br2O2
- IUPAC Name:
- 2,2-bis(bromomethyl)propane-1,3-diol
- Details on test material:
- 2,2-bis(bromomethyl)-1,3-propanediol (CAS No. 3296-90-0)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Age: 24 weeks old on arrival
Weight: 2.75-3.3 kg
Housed individually in suspended galvanaised and stainless steel cages in batteries, measured 0.6 x 0.6 x 0.4 m high and were fitted with mesh floors and automatic watering.
Animals had a free access to a commercially available standard pelleted rabbit diet and to water monitored regularly for chlorinated hydrocarbon
contaminants.
Acclimation: All rabbits were held for a period of not less than six days before entering the study during which time their health state was regularly assessed and any animal showing sign of disease or abnormality was replaced.
Environmental conditions:
Slight possitive air pressure
Temperature: 15° ± 2°C; Humidity 50% ± 10% R.H; Lighting restricted to 14 hours in any period of 24 hours.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded skin was tested
- Vehicle:
- water
- Remarks:
- Slightly moistened with distilled water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24hours
- Observation period:
- Each animal was observed for seven days with the proviso that earlier termination would be carried out if undue suffering became apparent, but only after consultation with senior scientists or the sponsor.
- Number of animals:
- 6
- Details on study design:
- The irritance of each concentration was assessed in six rabbits following the procedure described in the U.S. Federal Register, §191.11, 17 September1964. The official text for this is as follows:
Primary irritationto the skin is measured by a patch test technique on the abraded and intact skin of the albino rabbit clipped free of hair. A minimum of six subjects is used in abraded and intact skin tests. Introduced under a square patch such as surgical gauze measuring 1 inch x 1 inch, two single layers thick, 0.5 gram of the test substance. Dissolve solids in appropriate solvent and apply the solution as for liquids. The animals were immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material such as rubberized cloth for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances.
After 24 hours exposure, the patches are removed and the resulting reactions are evaluated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- Upon single dermal application a barely discernible erythematous response on the abraded skin of one aanimal at 72 hours accounted for a Primary Irritation Index of zero. Bandage burn was recognised on 3 animals and slight exfoliatio n was present in one animal on day 8.
- Other effects:
- None
Any other information on results incl. tables
Scoring of irritance responses elicited by single dermal application of 0.5 gr Dinol, supplied, under a 24-hr occlusive bandage
Score at day 7 |
Overall score |
Score at 72 hr |
Score at 24 hr |
Type of response |
Animal number and sex |
0;0 |
0 |
0;0 |
0;0 |
Erythema;Oedema (Intact skin) |
XR 295 Female |
0;0 |
0 |
0;0 |
0;0 |
Erythema;Oedema (Abraded skin) |
XR 295 Female |
0;0 |
0 |
0 (Periphery of treatment site subject to mechanical abrasion by adhesive bandage);0 |
0 (Periphery of treatment site subject to mechanical abrasion by adhesive bandage);0 |
Erythema;Oedema (Intact skin) |
XR 298 Female |
0 (slight exfoliation);0 |
0 |
0 (Periphery of treatment site subject to mechanical abrasion by adhesive bandage);0 |
0 (Periphery of treatment site subject to mechanical abrasion by adhesive bandage);0 |
Erythema;Oedema (Abraded skin) |
XR 298 Female |
0;0 |
0 |
0;0 |
0;0 |
Erythema;Oedema (Intact skin) |
XR 300 Female |
0;0 |
0 |
0;0 |
0;0 |
Erythema;Oedema (Abraded skin) |
XR 300 Female |
0;0 |
0 |
0 (Periphery of treatment site subject to mechanical abrasion by adhesive bandage);0 |
0 (Periphery of treatment site subject to mechanical abrasion by adhesive bandage);0 |
Erythema;Oedema (Intact skin) |
XR 301 Female |
0;0 |
0 |
1 (Periphery of treatment site subject to mechanical abrasion by adhesive bandage);0 |
0 (Periphery of treatment site subject to mechanical abrasion by adhesive bandage);0 |
Erythema;Oedema (Abraded skin) |
XR 301 Female |
0;0 |
0 |
0;0 |
0;0 |
Erythema;Oedema (Intact skin) |
XR 302 Female |
0;0 |
0 |
0;0 |
0;0 |
Erythema;Oedema (Abraded skin) |
XR 302 Female |
0;0 |
0 |
0;0 |
0 (Periphery of treatment site subject to mechanical abrasion by adhesive bandage);0 |
Erythema;Oedema (Intact skin) |
XR 303 Female |
0;0 |
0 |
0;0 |
0 (Periphery of treatment site subject to mechanical abrasion by adhesive bandage);0 |
Erythema;Oedema (Abraded skin) |
XR 303 Female |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- A single dermal application of test substance produced a Primary Irritation Index of zero. Thus placing the material into the lowest available class of ‘mildly irritating’ to the skin.
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