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Diss Factsheets

Administrative data

Description of key information

Skin irritation/corrosion: New Zealand white rabbit; strong erythema developed


Eye irritation: New Zealand white rabbit; Cornea diffuse opaque

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Small cellulose lobes (2.5 x 2.5 cm²) with ca. 500 µl of 4-trifluoromethoxyphenyl isocyanate was applied to the inner surface of one ear per animal; exposure time was 1 or 2 hours. The test-substance was fixed by a plaster. The post exposure observation time was 7 days.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
1 or 2 hours
Observation period:
7 days
Number of animals:
1 animal/exposure time
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: application: 2 hours
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 6, 7 days
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: application: 2 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 48, 72 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: application: 2 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 6, 7 days
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: application: 2 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: application: 1 hour
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 6, 7 days
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: application: 1 hour
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: application: 1 hour
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 6, 7 days
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: application: 1 hour

Up to 24 hours the treated skin areas are within the physiological norm. From day 2 of the post-observation period a strong erythema developed. From day 6 a strong erythema and a moderate edema was found.

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Remarks:
Based on EU GHS criteria
Conclusions:
Up to 24 hours the treated skin areas are within the physiological norm. From day 2 of the post-observation period a strong erythema developed. From day 6 a strong erythema and a moderate edema was found. 4-trifluoromethoxyphenyl isocyanate is irritating.
Executive summary:

Small cellulose lobes (2.5 x 2.5 cm²) with ca. 500 µL of 4-trifluoromethoxyphenyl isocyanate was applied to the inner surface of one ear per animal; exposure time was 1or 2 hours. The test-substance was fixed by a plaster. The post exposure observation time was 7 days.


Up to 24 hours the treated skin areas are within the physiological norm. From day 2 of the post-observation period a strong erythema developed. From day 6 a strong erythema and a moderate edema was found. 4-trifluoromethoxyphenyl isocyanate is irritating.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
100 µl test substance was applied into the conjuctival sac of 2 rabbits. Eyes were examinated after application of test substance up to 7 days
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2 animals
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 6, 7 days
Score:
2.2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 6, 7 days
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 6, 7 days
Score:
1.9
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.9
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.8
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 6, 7 days
Score:
0.8
Max. score:
2
Reversibility:
not fully reversible within: 7 days

4-trifluoromethoxyphenyl isocyanate is irriating

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Based on EU GHS criteria
Conclusions:
The conjunctiva was reddened and moderately swollen; the iris was slight to moderately swollen. The cornea was diffuse opaque. 4-trifluoromethoxyphenyl isocyanate is irriating to the eyes.
Executive summary:

100 µl test substance was applied into the conjuctival sac of 2 rabbits. Eyes were examinated after application of test substance up to 7 days. During the whole post-observation period the following symptoms were observed: The conjunctiva was reddened and moderately swollen; the iris was slight to moderately swollen. The cornea was diffuse opaque. 4-trifluoromethoxyphenyl isocyanate is irriating to the eyes.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

In the skin irritation/corrosion test up to 24 hours the treated skin areas were within the physiological norm. From day 2 of the post-observation period a strong erythema developed. From day 6 a strong erythema and a moderate edema was found. Within the post-observation time the findings were not reversible.

In the eye irritation test, during the whole post-observation period the following symptoms were observed: The conjunctiva were reddened and moderately swollen; the iris was slight to moderately swollen. The cornea was diffuse opaque. Within the post-observation time the findings were not reversible.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Due to the result of the irreversibility of the findings, for skin irritation/corrsion Skin Corr.1C;H314: Causes severe skin burns and eye damage and for eye irritation Eye Dam.1; H318 according to Regulation (EC) No 1272/2008 is justified.


In addition, respiration irritational effects were reported in the acute inhalation toxicity study (7.2.2). Therefore H335 is applicable.