Registration Dossier

Administrative data

Description of key information

The test substance TBBS showed a practically non-irritating potential to rabbit skin (Monsanto Co. 1982). The even very low skin irritation potential is confirmed by two additional skin irritation studies (Monsanto Co. 1973, 1982b). A rather slight and transient eye irritation potential is noted in an eye irritation study (Monsanto Co. 1973).

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP and comparable to guideline study with acceptable restrictions (e.g. no observation time point at 48 h post-treatment)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no 48 h observation time point, 24 h exposure time, intact and abraded skin tested
Principles of method if other than guideline:
The skin irritation potential of the test substance TBBS was evaluated in a skin irritation study with six New Zealand albino male and female rabbits. The test substance (500 mg) moistened with saline was applied under occlusive dressings to clipped intact and abraded skin of 6 New Zealand albino rabbits for 24 hours.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6 (3 males, 3 females)
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin sites
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
not determined
Remarks on result:
other:
Remarks:
score not determined at 48 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin sites
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin sites
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
4
Reversibility:
other:
Remarks:
not determined
Remarks on result:
other:
Remarks:
score not determined at 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: intact skin sites

Slight erythema and edema were observed at 24 hours after treatment at the abraded sites. No erythema or edema were noted on the intact skin sites at 24 and 72 hours after treatment. No signs of erythema or edema were visibile at 72 hours at the abraded sites and the study was terminated.

Total Draize score: 0.1

Interpretation of results:
GHS criteria not met
Conclusions:
No erythema or edema were noted on the intact skin sites at 24 and 72 hours after treatment.
Executive summary:

The skin irritation potential of the test substance TBBS was evaluated in a skin irritation study with six New Zealand albino male and female rabbits (Monsanto Co. 1982). The test substance (500 mg) moistened with saline was applied under occlusive dressings to clipped intact and abraded skin of 6 New Zealand albino rabbits for 24 hours.

Slight erythema and edema were observed at 24 hours after treatment at the abraded sites. No erythema or edema were noted on the intact skin sites at 24 and 72 hours after treatment. No signs of erythema or edema were visibile at 72 hours at the abraded sites and the study was terminated.

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited but acceptable documented study report which meets basic scientific principles
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
6 animals
Irritation parameter:
other: Draize score
Basis:
mean
Time point:
24/48/72 h
Score:
2.5
Max. score:
110
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
7.6
Max. score:
20
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: (conjunctiva + chemosis + discharge) x 2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
7.6
Max. score:
20
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: (conjunctiva + chemosis + discharge) x 2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 h

The test substance was slightly irritating to the rabbit eye (mean irritation score 24, 48, and 72 hours: 2.5/110.0). Effects on the conjunctivae were noted in all animals at 24 hours (mean score 24 h: 7.6/110) but were reversible within 48 hours. The test substance was classified as not eye irritating according to F.H.S.A.


EU mean chemosis score: 0
EU mean corneal score: 0
EU mean iritis score: 0
Draize score: 2.5/110

Interpretation of results:
GHS criteria not met
Executive summary:

100 mg of finely ground Santocure NS vulcanization accelerator was placed into the conjunctivial sac of 6 New Zealand albino male and female rabbits. A 7-d observation period followed application. Eye responses were scored in accordance with the Federal Hazardous Substances Act, 21 CFR, § 191.12 (1964).

The test substance was slightly irritating to the rabbit eye (mean irritation score 24, 48, and 72 hours: 2.5/110.0). Effects on the conjunctivae were noted in all animals at 24 hours (mean score 24 h: 7.6/110) but were reversible within 48 hours. The test substance was classified as not eye irritating according to F.H.S.A.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

The skin irritation potential of the test substance TBBS was evaluated in a skin irritation study with six New Zealand albino male and female rabbits (Monsanto Co. 1982). The test substance (500 mg) moistened with saline was applied under occlusive dressings to clipped intact and abraded skin of 6 New Zealand albino rabbits for 24 hours. The test substance TBBS was practically non-irritating to rabbit skin (mean erythema and edema score intact skin: 0).

This finding is confirmed by two other skin irritation studies, which also indicated a very low skin irritation potential of the test substance (Monsanto Co. 1973, 1982b).

Eye

The eye irritating potential of the test substance TBBS was evaluated in an eye irritation study with New Zealand albino male and female rabbits (Monsanto Co 1973). 100 mg of the finely ground test substance was placed into the conjunctival sac of six male and female rabbits. A 7-day observation period followed the application of the test substance. Eye response were scored in accordance with the Federal Hazardous substances Act (F.H.S.A.), 21 CFR, § 191.12 (1964).

The test substance was slightly irritating to the rabbit eye (irritation score 24, 48, and 72 hours: 2.5/110.0). Effects on the conjunctivae were noted in all animals at 24 hours (mean score 24 h: 7.6/110) but were reversible within 48 hours. The test substance was classified as not eye irritating according to F.H.S.A.


Justification for selection of skin irritation / corrosion endpoint:
GLP and comparable to guideline study with acceptable restrictions (e.g. no observation time point at 48 h post-treatment).

Justification for selection of eye irritation endpoint:
Limited but acceptable documented study report which meets basic scientific principles.

Justification for classification or non-classification

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.