Registration Dossier

Administrative data

Description of key information

In conclusion, the test substance 7PPD showed a practically non-irritating potential to rabbit skin (Monsanto Co. 1973). The even very low skin irritation potential is confirmed by another skin irritation study (Monsanto Co. 1967a). A rather slight and transient eye irritation potential is noted in an eye irritation study (Monsanto Co. 1973). This finding is supported by an earlier eye irritating study, which revealed mild and transient eye irritating effects of 7PPD (Monsanto Co. 1967a). 

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:
other: 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:
not required
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 skin irritation observed
Remarks on result:
other: slight defatting effect

slight defatting effect, skin flaked off in seven to ten days. No injury in deph.

Interpretation of results:
not irritating
Remarks:
Migrated information
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:
other: eye irritation study in vivo
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 d
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
3.5
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: slightly erythema, discharge
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
6.6
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: slight erythema, moderate to copious discharge
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
3.6
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: slight erythema, slight discharge

Immediate after application: slight discomfort

1 hour after application: slight erythema, very slight edema, copious discharge

Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin

The skin irritation potential of the test substance 7PPD was evaluated in a skin irritation study with six New Zealand Albino rabbits (Monsanto Co.1973). The undiluted test substance (0.5 ml) 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. The test substance 7PPD was practically non-irritating to rabbit skin (mean irritation score intact and abraded skin: 0). However, a slight defatting effect (skin flaked off in seven to ten days) were observed. In an earlier skin irritation study transient and mild skin irritating effects were noted in treated rabbits (maximum score 2.3/8 at 24 h). The effects were fully reversible within 120 hours after treatment (Monsanto Co. 1967).

Eye

The eye irritating potential of the test substance 7PPD was evaluated in an eye irritation study with six New Zealand albino rabbits (Monsanto Co 1973). The undiluted test substance (0.1 ml) was placed into eyes of six 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: 3.5/110.0). Effects on the conjunctivae were noted in all animals at 24 and 48 hours (mean score 24 h: 6.6/110, 48 h: 3.6) but were reversible within 72 hours. The test substance was not classified as eye irritating. In an earlier eye irritation study with rabbits, the test substance was classified as mild irritant with an average maximum irritation score of 24.3/110 one hour after treatment and average irritation scores of 19.3, 13.0, 7.0 and 2.6 at 24, 48, 72 and 120 hours, respectively. The effect was fully reversible after 168 hours (Monsanto Co. 1967).

Justification for classification or non-classification

No classification is required according to the classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).