Registration Dossier

Administrative data

Description of key information

In conclusion, the test substance MBTS showed a practically non-irritating potential to rabbit skin (Monsanto Co. 1973). This negative finding was confirmed in a Repeated Insult Patch Test with human volunteers (Monsanto Co. 1982). A low eye irritation potential of MBTS was revealed in an eye irritation study with New Zealand albino rabbits (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: limited but acceptable documented study report which meets basic scientific principles
Principles of method if other than guideline:
In vivo skin irritation study
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
8
Reversibility:
other: no effects observed
Remarks on result:
other: no effects

No skin irritating effects observed in any of the treated animals.

Interpretation of results:
GHS criteria not met
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:
In vivo eye irritation study
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.6
Max. score:
110
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: immediate: slight discomfort, 10 min: slight erythema, moderate discharge

Immediate: slight discomfort

10 minutes: slight erythema, moderate discharge

1 hour: slight erythema, moderate discharge

24 hours: slight erythema (mean score 24 h: 2/110)

48 hours: all scored zero

Interpretation of results:
GHS criteria not met
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 MBTS was evaluated in a skin irritation study with six New Zealand Albino rabbits (Monsanto Co.1973). The finely ground test substance (0.5 mg) moistened with water was applied under semi-occlusive dressings to clipped intact and abraded skin of 6 New Zealand albino rabbits for 24 hours. A 7 day observation period followed the test substance application. Skin response were scored in accordance with the Federal Hazardous substances Act (F.H.S.A.), 21 CFR, § 191.12 (1964).The test substance MBTS was practically non-irritating to rabbit skin (mean irritation score intact and abraded skin 24 and 72 h average: 0).

The negative finding in animals was confirmed in a Repeated Insult Patch test (modified Shelanski 4 x 4 Method) with human volunteers (Monsanto Co. 1982). No indication of skin irritation (0/53 volunteers) was observed after repeated dermal application of the test substance (70% in petrolatum).

Eye

The eye irritating potential of the test substance MBTS was evaluated in an eye irritation study with six New Zealand albino rabbits (Monsanto Co. 1973). The finely ground test substance (100 mg) was placed into eyes of six rabbits. A 7-day observation period followed the application of the test substance. Eye responses 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 (mean irritation score 24, 48, and 72 hours: 0.6/110.0). Effects on the conjunctivae were noted in all animals at 24 hours (mean score 24 h: 2/110) but were reversible within 48 hours. The test substance was not classified as eye irritating.

Justification for classification or non-classification

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification for skin and eye irritation is not justified.