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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

IOMP is not irritating to skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
Reason / purpose for cross-reference:
reference to other study
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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: National Guideline study with acceptable restrictions.
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
The procedure recommended in Section 191.12 of the Federal Hazardous Substances Labeling act was used.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL


Duration of treatment / exposure:
observation period up to 7 days
Observation period (in vivo):
1, 2, 3, 4 and 7 day(s)
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- The eyes were not irrigated following instillation of the sample.


TOOL USED TO ASSESS SCORE: observations were made with the unaided eye as well as facilitated by magnification and ophthalmic fluorescin.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 day
Score:
0.4
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 2 days
Score:
0.4
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 3 days
Score:
0.4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
The material tested produced a very mild transient conjunctival irritation in one of six rabbits tested. No corneal or iridal damage was seen at any observation time.
Interpretation of results:
GHS criteria not met
Conclusions:
The material tested produced a very mild transient conjunctival irritation in one of six rabbits tested. No corneal or iridal damage was seen at any observation time.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation testing was not necessary, because a limit test for acute dermal toxicity showed no signs of skin irritation in rats exposed to undiluted IOMP for 24 h.

An eye irritation test in rabbits was negative.

Justification for classification or non-classification

The classification criteria of EU or CLP were not reached.