Registration Dossier

Administrative data

Description of key information

Skin irritation:
Mallory VT (1981) determined in a K2 study the skin irritation potential of NMMO in New Zealand White rabbits according to a method similar to OECD Guideline 404. NMMO was observed to be slightly irritating to the skin. This study was selected as key study.
Eye irritation:
Mallory VT (1981) determined in a K 1 study the eye irritation potential of NMMO in New Zealand White rabbits according to a method similar to OECD Guideline 405 and EU Method B.5. NMMO was observed to be slightly irritating to the eyes. This study was selected as key study.

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:
supporting study
Study period:
not indicated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP study performed according to method similar to OECD Guideline 405. No information provided on animals and housing conditions. No observations at 7 days (or later) in order to determine reversibility.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
No details on animals and housing conditions. No observations made at 7 days (or later).
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
No data
TEST ANIMALS
- Source: Sweetwater Farms
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite eyes were untreated and served as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
No data
Observation period (in vivo):
Examinations for gross signs of eye irritation were made at 24, 48 and 72 hours following application.
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
SCORING SYSTEM: Scoring of irritation effects was according to the method of Draize, in which corneal, iris, and conjunctival effects are scored separately.

Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
based on 6 animals
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
based on 6 animals
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
based on 6 animals
Time point:
other: 24, 48, 72h
Score:
0.72
Max. score:
3
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: No scoring later than 72h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
based on 6 animals
Time point:
other: 24, 48, 72h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Remarks:
based on 6 animals
Time point:
other: 24, 48, 72h
Score:
0.28
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritant / corrosive response data:
At the 24-hour reading, the sample produced no corneal opacity or iritis in any animal, and mild to moderate conjunctival erythema in four rabbits.
By the 48-hour reading, slight conjunctival erythema was noted in two rabbits.
By the 72-hour reading, slight conjunctival erythema was noted in one rabbit.
Conclusions:
Application of the substance to the eyes of New Zealand White rabbits produced conjunctival erythema in four rabbits. As no information is available on effects later than 72h, reversibility of shown effects cannot be judged. Therefore no definite classification can be derived.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion:

Mallory VT (1981) studied skin irritation/corrosion by applying NMMO on one intact and one abraded site. At the end of the 24 hour exposure period, the wrappings were removed and the skin wiped to remove any remaining material. Animals were observed for signs of erythema and edema and according to the Draize scale at 1, 24, 48 and 72 hours after the application of the test material. Slight erythema was visible only at one hour after bandage removal in 3 animals. No edema was observed throughout the study. Based on the observations made in the primary dermal irritation study in rabbits, the test article was not considered to be a dermal irritant.

In a supporting K2 study very slight erythema was noted at one abraded site at the 24-hour reading. No other irritative or corrosive effects were noted at any time. The primary irritation index was found to be 0.04.

Based on the results of these tests and the criteria of the CLP Regulation, the substance should not be classified for skin irritation.

Eye irritation:

Mallory VT (1981) studied eye irritation by applying 0.1 mL NMMO to the eye of 6 New Zealand White rabbits. The other untreated eye served as control. The eyes were examined at 1, 24, 48 and 72 hours and 7 days after treatment. An animal exhibited a positive reaction when the test substance produced one or more of the following signs: ulceration of the cornea (other than a fine stippling), opacity of the cornea (other than a slight dulling of the normal luster), inflammation of the iris (other than a slight deepening of the rugae or a light hyperemia of the circumcorneal blood vessels), or and obvious swelling in the conjunctivae (excluding the cornea and iris) with partial eversion of the eyelids and a diffuse crimson color with individual vessels not easily discernible. Five rabbits exhibited a positive response at the one hour observation period. Two rabbits exhibited a positive response at the 24 hour reading. One positive response was observed at the 48 hour reading. No positive responses were observed at 72 hour or on day 7. Eight positive responses were recorded during the course of the study. Based upon the observations in the Acute Eye Irritation Test in Rabbits, the authors determined the substance to be a mild eye irritant. However, based on the CLP classification criteria, the substance does not need to be classified for eye irritation.

In a supporting K2 study application of the substance to the eyes of New Zealand White rabbits produced conjunctival erythema in four rabbits. As no information is available on effects later than 72h, reversibility of shown effects cannot be judged. Based on this study no definite classification can be derived.


Effects on eye irritation: slightly irritating

Justification for classification or non-classification

According to the criteria of the DSD and CLP Regulation, NMMO should not be classified as irritating to the skin nor to the eyes.