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: limited documentation; no information on exposure time and conditions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1969

Materials and methods

Principles of method if other than guideline:
Method: 0.5 ml undiluted TS was applied to the intact and to the abraded skin, time of observation: 24 and 72 hours
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: m-Cresol, M.P.:11-12 C; B.P.: 202.8 C

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
not specified
Preparation of test site:
other: partly shaved intact skin, partly shaved and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
no data undiluted
Observation period:
up to 72 hours
Number of animals:
6
Details on study design:
evaluation of erythema and edema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Score:
ca. 8
Max. score:
8
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal: mean score of each animal
Time point:
other: abraded and intact skin: after 72 hours
Score:
ca. 4
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal: mean score of each animal
Score:
ca. 4
Max. score:
4
Reversibility:
no data
Irritant / corrosive response data:
All animals showed erythema (score 4 of max.4) and edema (score 4 of max.4) from the first observtion time point being reported (24h)
Other effects:
no data

Any other information on results incl. tables

RS-Freetext:
intact skin, erythema. edema: 24 hr: Score 4 in 6/6; 72 hr: Score 4 in 6/6
abraded skin, erythema, edema: 24 hr: Score 4 in 6/6; 72 hr: Score 4 in 6/6
no tissue destruction and/or necrosis reported, no further details reported
Summary: irritation score: 8.00/8.00

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Executive summary:

Application of 0.5 ml undiluted substance on shaved intact or abraded rabbit skin areas, coverage not mentioned, and reading up to 72 hours post application yielded mean irritation score 8 of max 8. reversibility is not reported.