Registration Dossier

Administrative data

Description of key information

The available data suggest that NPEO is not irritating to skin or eyes.

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:
From 16 March to 06 July 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD Guideline 404 in compliance with GLP. Analytical certificate not included in study report.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: HC:NZW
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna Ltd., UK
- Housing: Macrolon Type III cages
- Diet (e.g. ad libitum): Standard Ssniff K4 diet (Soest/Westfalen GmbH)
- Water (e.g. ad libitum): tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2°C
- Humidity (%): ca. 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12:12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl undiluted substance
Duration of treatment / exposure:
4 h
Observation period:
14 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage:
- Type of wrap if used: substance applied rto hypoallergenic Hansamed bandage (Beiersdorf 2342), fixed with an elsatic bandage to provide semi-acclusive conditions

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize
Remarks on result:
other: see below section 'Irritant/corrosive response data'
Irritant / corrosive response data:
No effects observed in two animals. Grade 1 erythema seen until and including 48 h timepoint in one animal, no longer observed at 72 h. Overall score for this animal: 0.7
Other effects:
None

None

Conclusions:
Under the conditions of the study, the substance was not irritating to skin.
Executive summary:

A study was conducted to determine the skin irritation potential of NPEO in rabbit according to OECD Guideline 404. 500 µl of undiluted test substance were applied by patch under semi-occlusive conditions to the shaved skin of 3 rabbits. The patch was removed after 4 h and the skin washed with water. Erythema, scarring and eodema were evaluated after 1, 24, 48, 72 h and 7 and 14 d according to the Draize scoring system. Other effects were also recorded. No effects observed in two animals. Grade 1 erythema was seen until and including the 48 h timepoint in one animal, but no longer observed at 72 h. The overall score for this animal was 0.7. Based on these findings, the substance was considered to be non-irritating to skin under the conditions of the study (Märtins T, 1988).

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
Study period:
From 16 March to 06 July 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD Guideline 405 in compliance with GLP. Analytical certificate not included in study report.
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: HC:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna Ltd., UK
- Housing: Macrolon Type III cages
- Diet (e.g. ad libitum): Standard Ssniff K4 diet (Soest/Westfalen GmbH)
- Water (e.g. ad libitum): tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2°C
- Humidity (%): ca. 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12:12
Vehicle:
unchanged (no vehicle)
Controls:
other: One eye treated, the other left untreated and served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl
- Concentration (if solution): undiluted
Duration of treatment / exposure:
24 h, after which eye was rinsed with saline solution.
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with saline solution
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No effects reported on cornea, iris or conjunctiva at any of the timepoints.
Other effects:
None

None

Conclusions:
Under the conditions of the study, the substance was not irritating to eyes.
Executive summary:

A study was conducted to determine the eye irritation potential of the substance in rabbit according to OECD Guideline 405. 100 µl of undiluted substance were instilled into one eye of each of 3 rabbits, then rinsed after 24 hours with saline solution. The other eye was left untreated and served as control. Effects on cornea, iris and conjunctivae were evaluated after 1, 24, 48 and 72 h, as well as after 7, 14 and 21 d according to the Draize scoring system. Other effects were also recorded. No symptoms were observed at any of the time points. Based on these findings, the substance was considered to be non-irritating to eyes under the conditions of the study (Märtins T, 1988).

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

A study was conducted to determine the skin irritation potential of NPEO in rabbit according to OECD Guideline 404. A volume of 500 µL undiluted substance were applied by patch under semi-occlusive conditions to the shaved skin of 3 rabbits. The patch was removed after 4 h and the skin washed with water. Erythema, scarring and oedema were evaluated after 1, 24, 48, 72 h and 7 and 14 days according to the Draize scoring system. Other effects were also recorded. No effects observed in two animals. Grade 1 erythema was seen until and including the 48 h time point in one animal, but no longer observed at 72 h. The overall score for this animal was 0.7. Based on these findings, the substance was considered to be non-irritating to skin under the conditions of the study (Märtins T, 1988).

Another earlier study was conducted to determine the skin irritation potential of NPEO in rabbit. In this test, a primary irritation index of 4 out of 8 was found, suggesting that the substance may be moderately irritating (Cuthbert JA, 1975). However, the study was not run according to guidelines and is older than that of Märtins (1988). The results were therefore considered to be superseded by the more recent test.

Eye

A study was conducted to determine the eye irritation potential of NPEO in rabbit according to OECD Guideline 405. A volume of 100 µL undiluted substance were instilled into one eye of each of 3 rabbits, and then rinsed after 24 h with saline solution. The other eye was left untreated and served as control. Effects on cornea, iris and conjunctivae were evaluated after 1, 24, 48 and 72 h, as well as after 7, 14 and 21 days according to the Draize scoring system. Other effects were also recorded. No symptoms were observed at any of the time points. Based on these findings, the substance was considered to be non-irritating to eyes under the conditions of the study (Märtins T, 1988).

Justification for classification or non-classification

Based on the available skin and eye irritation data on NPEO, the substance does not require classification for these endpoints according to CLP (EC 1272/2008) and DSD (67/548/EEC) criteria.