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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

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: OECD Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: EC guideline B.4.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-chlorophenyl isocyanate
EC Number:
222-023-7
EC Name:
2-chlorophenyl isocyanate
Cas Number:
3320-83-0
Molecular formula:
C7H4ClNO
IUPAC Name:
1-chloro-2-isocyanatobenzene
Details on test material:
Purity: 99.7%

Test animals

Species:
rabbit
Strain:
Himalayan

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated flank of the same animals served as control
Duration of treatment / exposure:
4 hr
Observation period:
14 d
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 60 min
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours up to 10 days
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 10 d
Other effects:
Moderate necrosis observed in all animals from 24 hours up to 5 days.
From day6 to day 10 slight necrosis was observed.
Labelling requirements: R34

Any other information on results incl. tables

Acute skin irritation test of o-Chlorphenylisocyanat in rabbits (patch test)

 Findings of the skin  Examination schedule        Skin irritation scores
           Animal Number
     1  2  3
             0.5 ml o-Chlorphenylisocyanat/ animal

 erythema and eschar formation.

oedema formation

 before dosing  E0/0e0   E0/0e0   E0/0e0
   time after removal of the patch (4 hour exposure)        
   60 min   E0/0e0  E0/0e0    E0/0e0
   24 hrs  E4#/0e0   E4#/0e0  E4#/0e0 
   48 hrs   E4#/0e0   E4#/0e0  E4#/0e0 
   72 hrs   E4#/0e0  E4#/0e0    E4#/0e0
   4 days   E4#/0e0  E4#/0e0    E4#/0e0
   5 days   E4#/0e0  E4#/0e0    E4#/0e0
   6 days   E4##/0e0   E4##/0e0   E4##/0e0
   7 days   E4##/0e0   E4##/0e0  E4##/0e0 
   8 days   E4##/0e0   E4##*/0e0   E4##*/0e0
   9 days   E4##*/0e0  E4##*/0e0    E4##*/0e0
   10 days   E4##*/0e0   E4##*/0e0   E4##*/0e0
   11 days   E0**/0e0   E0**/0e0  E0**/0e0 
   12 days   E0***/0e0   E0***/0e0  E0***/0e0 
   13 days   E0***/0e0   E0***/0e0  E0***/0e0 
   14 days   E0***/0e0  E0***/0e0    E0***/0e0

0 = no pathological findings

E =erythema/ eschar formation (4=severe erythema (beet redness) to slight preventing erythema reading)

Oe=oedema

# = moderate necrosis

## = slight necrosis

* = laceration

** = peeling, new skin

*** = new skin

Applicant's summary and conclusion

Executive summary:

In a skin irritation study according OECD Guideline 404 3 male rabbits were exposed for 4 hours to 0.5 ml test substance/ patch and animal under semi-occlusive conditions. The first 60 minutes no effects were observed in all animals.

Beginning at 24hours up to 10 days erythema were observed in all animals. In addition, in all 3 rabbits moderate necrosis was observed 24 hours to 5 days and slight necrosis 6 days to 10 days after patch removal. The rabbit skin showed lacerations 8 to 10 days after patch removal, peeling and new skin at the 11th day and new skin from 12 to 14 days after patch removal.

There were no systemic intolerance reactions.

The test substance causes burns to skin (labeling requirements: R34).