Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards; sufficiently documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
0.5 ml of undiluted compound was applied to the clipped, intact abd abraded skin of six albino male and female rabbits under a one inch by one inch square patch, two single layers thick. The patches were held in place with adhesive tape. The trunk of each animal was wrapped with plastic strips, to retard evaporation and avoid contamination, for the 24-hr exposure period. Observations were made over a period of seven days. The data were scored according to the method of Draize, Woodard and Calvery (Journal of Pharm. and Exp. Therapeutics, Vol. 82, Dec. 1944).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Mondur PF; no further data given

Test animals

Species:
rabbit
Strain:
other: albino
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved (intact) and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Amount(s) applied: 0.5 ml/animal
Duration of treatment / exposure:
24 hours
Observation period:
1, 24, 48, 72 hours and 5, 7 days after removal of patches
Number of animals:
intact skin: 3 males and 3 femals,
abraded skin: 3 males and 3 femals
Details on study design:
see "Principles of method"

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: erythema score (intact skin)
Basis:
animal: #1, 2, 3, 4, 5, 6
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score after 24, 48 and 72 hours: 2.0
Irritation parameter:
other: edema score (intact skin)
Basis:
animal: #1, 2, 3, 4, 5, 6
Time point:
other: 24, 48, 72 hours
Score:
1 - 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score after 24, 48 and 72 hours: 1.1
Irritation parameter:
other: erythema score (abraded skin)
Basis:
animal: #1, 2, 3, 4, 5, 6
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score after 24, 48 and 72 hours: 2.0
Irritation parameter:
other: edema score (abraded skin)
Basis:
animal: #1, 2, 3, 4, 5, 6
Time point:
other: 24, 48, 72 hours
Score:
1 - 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score after 24, 48 and 72 hours: 1.4
Irritant / corrosive response data:
Observations following application (intact and abraded skin):
1 hour: no erythema or edema (zero readings)
24 hours: slight erythema, very slight to slight edema
48-120 hours: gradual improvement
168 hours: all scored zero
Other effects:
none

Any other information on results incl. tables

The author specified a Primary Irritation Score (together for erythema and edema, intact and abraded skin, 24 and 72 hour readings) of 3.1. Note: The term 'primary irritant' is given to a substance which produced an empirical score ( Primary Irritation Score) of 5 or more when tested by the method described.

Applicant's summary and conclusion

Executive summary:

Mondur PF was not classed as a primary skin irritant in a skin irritation test on male and female rabbits after occlusive conditions. 24 hours after application slight erythema and very slight to slight edema were observed. All effects were fully reversible within 7 days.