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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:
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:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
2,2-bis(bromomethyl)-1,3-propanediol (CAS No. 3296-90-0)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.