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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In the skin irritation study, no irritation or corrosion were observed.  In the eye irritation study, no corrosion was observed but ocular, iridial, and/or conjunctival irritation was observed in all rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

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: OECD guideline study conducted under GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan, France
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21.4
- Humidity (%): 42 - 70
- Air changes (per hr): 16
- Photoperiod (hrs dark / hrs light):12 hrs

Vehicle:
unchanged (no vehicle)
Controls:
other: one eye was untreated and served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration : 100%

Duration of treatment / exposure:
lids held together for 1 sec
Observation period (in vivo):
24, 48, and 72 hour, 7 days, and 14 days after exposure
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 47, and 72 hours
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hour
Score:
0.5
Max. score:
0.7
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24, 48, and 72 hr
Score:
1.67
Max. score:
2.3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
mean
Time point:
other: 24, 48, and 72 hr
Score:
ca. 1
Max. score:
1.3
Reversibility:
fully reversible within: 7 days
Other effects:
No clinical signs of toxicity noted
Interpretation of results:
irritating
Remarks:
Migrated information Category A2 Criteria used for interpretation of results: OECD GHS
Conclusions:
MPKO is irritating to rabbit eyes
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Based on GHS criteria, OS1600 is category 2.