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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation/corrosion: not irritating (eq. OECD 404, non-GLP, Key, Rel. 2). 


Eye irritation: corrosive (eq. OECD 405, non-GLP, Key, rel.1)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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: equivalent to OECD 404
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: polyethylene glycol 400
Controls:
not required
Duration of treatment / exposure:
24
Observation period:
30-60 min, 24, 48, 72 h, 7 and 14 d after removal of plaster
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Other effects:
no data
no data
Interpretation of results:
GHS criteria not met
Executive summary:

patch test: 4 h semiocclusive on 3 rabbits

result: mildly irritating

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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: well documented and scientifically acceptable
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1, 24, 48 and 72 h after application
Number of animals or in vitro replicates:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 7 days (score of 3.0 on Day 7)
Remarks on result:
probability of severe irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 7 days (score of 2.0 on Day 7)
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days (score of 3.0 at Day 7)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days (score of 1.0 at Day 7)
Other effects:
24 to 72 hours white, viscous discharge

time post application 1h 24h 48h 72h 7d

animal no 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3

chemosis 2 3 2 3 4 4 2 3 3 2 3 3 0 2 1

conjuctivae 2 2 2 3 3 3 3 3 3 2 3 3 0 2 1

iris 0 0 0 1 1 1 0 1 1 0 1 1 0 0 0

cornea 1 2 1 1 1 1 1 2 2 1 2 2 0 3 2

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Classification: risk of serious damage to eyes
Executive summary:

method: single application of 0.1 g 3,4 -dichlorophenyl isocyanate into the conjunctival sac of 3 rabbits

result: substance is irritating to the eye (risk of serious damage to eyes)

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation


In a guideline study performed similarly to OECD TG 404 and under GLP (Kreiling/Jung, 1988), 3,4-dichlorphenyl isocyanate was found to be mildly irritating. Mean scores (24/48/42 hrs) for the three animals were 1.2 for erythema and 0.7 for oedema. Individual scores are not available.


Other studies reported similar results.


Based on the available data, 3,4-dichlorphenyl isocyanate is not classified as a skin irritant.


 


Eye irritation / damage


A guideline study performed according to OECD TG 405 and under GLP (Kreiling/Jung, 1988) revealed a risk of serious damage to eyes.


Mean (24/48/72 hrs) individual cornea opacity score : 1.0 / 1.7 / 1.7. No reversibility and increase effects were noted at Day 7.


Mean (24/48/72 hrs) individual iris score : 0.33 / 1.0 / 1.0. Recovery at Day 7.


Mean (24/48/72 hrs) individual conjunctival redness score : 2.3 / 3.0 /3.0. Partial recovery at Day 7.


Mean (24/48/72 hrs) individual conjunctival oedema (chemosis) score : 2.3 / 3.3 / 3.3. Partial recovery at Day 7.


 


This findings were supported by another study (Lamb, 1975) where 3,4 -dichlorphenyl induced strong ulceration of the conjunctiva after 5 min or 24 hours exposure.


Based on the available data, 3,4-dichlorphenyl isocyanate is classified as corrosive to the eyes.

Justification for classification or non-classification

Harmonised classification:


The substance has no harmonised classification for irritation / corrosion according to the Regulation (EC) No. 1272/2008 (CLP). 


 


Self classification:


Based on the available information no additional self-classification is proposed regarding skin irritation according to the CLP and to the GHS. 


For effects on eyes, the substance is classified as Eye Damage Category 1 (H318: Causes serious eye effects).


No data was available regarding respiratory irritation, however based on effects on eyes, a classification as STOT SE3 (H335: May cause respiratory irritation) is applied.