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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

 Tris(p-isocyanatophenyl) thiophosphate is slightly irritating to the pulmonary tissue of rats after single nose-only inhalation exposure for 6 hours. The trade product with about 27%  tris(p-isocyanatophenyl) thiophosphate in ethyl acetate is slightly irritating to the skin of rabbits and not irritating to the eye of rabbits.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: appr. 4.5 months
- sex: males
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: surrounding untreated skin area of test animals served as control
Amount / concentration applied:
Amount: 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours,  and 4 days after application; maximal observation time 24 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: non irritating tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal: #1-#3
Time point:
other: 24 and 48 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
day 4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
day 4
Irritation parameter:
erythema score
Basis:
animal: #1 and #3
Time point:
other: 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1 - #3
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
4
Other effects:
There were no systemic intolerance reactions.
Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:




Classification: not irritating
Executive summary:

In a study performed according to OECD 404 the test item (27% tris(p-isocyanatophenyl) thiophosphate in ethyl acetate) was shown to be slightly irritating to the rabbit's skin. Erythema grade 1 was observed in all 3 animals 24 and 48 hours after treatment. These effects disappeared on day 3 to 4 after treatment. No systemic intolerance reactions were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: female
- Source: LPT Laboratory of Pharmacology and Toxicology KG, Löhndorf, Germany
- Age at study initiation: appr. 3.5 months
- sex: males
Vehicle:
unchanged (no vehicle)
Controls:
other: one untreated eye of test animals served as control
Amount / concentration applied:
Amount: 0.1 ml

Duration of treatment / exposure:
single treatment; the lid was held together for about one second after instillation
Observation period (in vivo):
the eyes were examined ophthalmoscopically with a slit lamp prior to the administration and also 1, 24, 48, 72 hours post application. 24 hours after administration the eyes were treated additionally with fluorescein and examined.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none

SCORING SYSTEM: Draize
Irritation parameter:
overall irritation score
Remarks:
cornea, iris, and conjunctivae
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: 1 hour after instillation redness of conjunctivae (grade 1; all animals), chemosis (grade 1; 1 animal) , and cornea opacity (grade 1; 2 animals) was observed
Other effects:
There were no systemic intolerance reactions.
Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:



Classification: not irritating
Executive summary:

In a study performed according to OECD 405 the test item (27% tris(p-isocyanatophenyl)thiophosphate in ethyl acetate)

did not induce irritant effects in the eye of rabbits. There were no systemic intolerance reactions.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Tris(p-isocyanatophenyl) thiophosphate is marketed and handled as solution in ethyl acetate containing approximately 27% of tris(p-isocyanatophenyl) thiophosphate. Removal of the solvent from a solution of 27% of tris(p-isocyanatophenyl) thiophosphate in ethyl acetate does invariably lead to generation of higher molecular weight species. This is due to the inherent reactivity of the isocyanate moieties and the process can thus be monitored via the decrease of the isocyanate content (see IUCLID section 1.4: analytical material balances before/after solvent removal). Therefore, a solution of 27% of tris(p-isocyanatophenyl) thiophosphate in ethyl acetate was employed as test substance for all toxicological tests as this was believed to best represent the substance to be registered.

Skin irritation/corrosion
In a study performed according to OECD 404 the test item (27% tris(p-isocyanatophenyl) thiophosphate in ethyl acetate) was shown to be slightly irritating to the rabbit's skin. Erythema grade 1 was observed in all 3 animals 24 and 48 hours after treatment. These effects disappeared on days 3 to 4 after treatment. No systemic intolerance reactions were observed.

Eye irritation/severe eye damage
In a study performed according to OECD 405 the test item (27% tris(p-isocyanatophenyl) thiophosphate in ethyl acetate) did not induce irritant effects in the eye of rabbits. There were no systemic intolerance reactions.

Respiratory tract irritation

In an inhalation toxicity study performed on rats according to OECD 403 and TRGS 430 (see IUCLID section 7.2.2) the aerosolized test item (active ingredient) was shown to be a slight pulmonary irritant. The exposure level considered to be the NOAEL for pulmonary irritation was determined with 5.6 mg/m³.


Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Justification for selection of eye irritation endpoint:
Only one study available.

Justification for classification or non-classification

No classification is required with regard to skin, eye and respiratory tract irritation.