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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: p-chlorophenyl isocyanate, no data on purity

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
14 d
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
1.66
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
2.16
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
3
Max. score:
4
Reversibility:
not reversible
Other effects:
no data

Any other information on results incl. tables

RS-Freetext:
Erythema (score 2 of max.4) and oedema (day 1: score 2-3,
from day 2: score 3 of max.4) appeared on day 1 in all
animals. 
Desquamation was observed from day 5 until the end of the
observation period (day 14).  
On Day 14 erythema disappeared in one animal only, but
persisted in the 5 others (4/5: score 1, 1/5: score 2 of max
4 and desquamation). Oedema was still seen in all animals
(2/6: score 1 and 4/6: score 2 of max.4)

Applicant's summary and conclusion

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

method: the study was conducted according to the recommendations of the OECD guideline no 404.

result: erythema and oedema apperared on day 1 in all animals. the reactions were very important and induced a desquamation from day 5 until the end of the observation period (day 14). on day 14, erythema disapperared in one animal only, but persisted in the five others. oedema was still seen in all animals. the compound was considered as irritant.