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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 sensitisation: strong skin sensitiser (eq. to OECD 406, GLP, K, rel.2)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
On day 1, 0.1 ml of the test substance was administered by intradermal route at the concentration of 0.1 % in paraffin oil and on day 9 0.5 ml of the test substance was applied by cutaneous route at the concentration of 1%. After a period of 15 days without treatment, a challenge cutaneous application of the vehicle (left flank) and the test substance at the concentration of 1% (right flank) was performed in all the animals. The test substance and the vehicle were held in contact with the skin for 24 hours by an occlusive dressing. The cutaneous reactions were evaluated at the challenge application site, 24 hours and 48 hours after the removal of the dressing.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA method was not available yet by the time the study was conducted
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
1%
Day(s)/duration:
Day 9
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
0.1 %
Day(s)/duration:
Day 1
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
1%
Day(s)/duration:
Day 24
Adequacy of challenge:
not specified
No. of animals per dose:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
erythema, oedema
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 %
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
erythema, oedema
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Remarks:
Migrated information
Executive summary:

On day 1, 0.1 ml of the test substance was administered by intradermal route at the concentration of 0.1 % in paraffin oil and on day 9, 0.5 ml of the test substance was applied by cutaneous route at the concentration of 1%. After a period of 15 days without treatment, a challenge cutaneous application of the vehicle (left flank) and the test substance at the concentration of 1% (right flank) was performed in all the animals. the test substance and the vehicle were held in contact with the skin for 24 hours by an occlusive dressing. The cutaneous reactions were evaluated at the challenge application site, 24 hours and 48 hours after the removal of the dressing.

result: positive

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The sensitisation potential of 3,4-dichlorphenyl isocyanate was evaluated in the guinea-pig by intradermal route and cutaneous application, according to the maximisation method of Magnusson and Kligman. A positive result was found under the experimental conditions.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

According RL 1272/2008/EG (GHS) a classification as Skin Sens.1A (H 317: May cause an allergic skin reaction) is warranted, based on comparative analysis regarding other isocyanates isocyanates (p-isopropylphenylisocyanate_CAS 31027-31-3, n-butylisocyanante_CAS 111-36-4, 3,4-dichlorphenylisocyanante_CAS 102-36-3, 3,5-dichlorphenylisocyanate_CAS 28479-22-3, phenylisocyanate_CAS 103-71-9, trifluormethoxyphenylisocyanate_CAS 35037-73-1 are all strong sensitisers, classified as Skin Sens. 1A). No classification for respiratory sensitisation is necessary (see discussion below).


There are no data on respiratory sensitization available. p-tolyl isocyanate is a monoisocyanate. The UK Health and Safety Commission Working Group on the Assessment of Toxic Chemicals, Working Group on Action to Control Chemicals concluded performed an assessment of the potential for isocyanic acid and other monoisocyanates to cause respiratory irritation and sensitization (WATCH Committee Paper WATCH/2008/4, 17 Jun., 2008; http://www.hse.gov.uk/aboutus/meetings/iacs/acts/watch/170608/p4.pdf) and came to the following conclusion: “With the exception of methyl isocyanate, information on the toxicity of the monoisocyanates is sparse. There is no direct evidence that any of the monoisocyanates can cause respiratory sensitisation. … However, this indirect information on the allergenicity and immunoreactivity of the monoisocyanates is very limited, and insufficient to reliably inform on their potential to cause respiratory sensitisation.” A similar conclusion was drawn by the German MAK commission concerning the monoisocyanates in 2009 (MAK- und BAT-Werteliste 2009).


 


In addition it should be also mentioned that the ‘default’ assumption of the former EU hazard classification systems that all isocyanates have the potential to cause respiratory sensitisation is not in agreement with the strategy for evaluating respiratory sensitisation data in the Technical Guidance Document (TGD) on information requirements for REACH (R.7a; page 256ff). The TGD proposes that, in the absence of specific health effects data, only diisocyanates that also meet the criteria for classification for skin sensitisation are presumed to be respiratory sensitisers.

Justification for classification or non-classification

 


Harmonised classification:


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


 


Self classification:


According RL 1272/2008/EG (GHS) a classification as Skin Sens.1A (H 317: May cause an allergic skin reaction) is warranted, based on comparative analysis regarding other isocyanates isocyanates (p-isopropylphenylisocyanate_CAS 31027-31-3, n-butylisocyanante_CAS 111-36-4, 3,4-dichlorphenylisocyanante_CAS 102-36-3, 3,5-dichlorphenylisocyanate_CAS 28479-22-3, phenylisocyanate_CAS 103-71-9, trifluormethoxyphenylisocyanate_CAS 35037-73-1 are all strong sensitisers, classified as Skin Sens. 1A). No classification for respiratory sensitisation is necessary (see discussion).