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Diss Factsheets

Administrative data

Description of key information

Skin irritation: not irritating

Eye irritation: not irritating

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:
August 25, 1992 - September 1, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Version / remarks:
EPA FIFRA Subdivision F Guideline 81-5 Primary dermal irritation, revised Edition November 1984
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- batch No.of test material: 5007
- sample No.:1505E
- Expiration date of the lot/batch: March 1993

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4°C in the dark





Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 10-14 weeks
- Weight at study initiation: 2.4 to 3.0 kg
- Housing:ndividually in plastic cages with perforated floors
- Diet: ad libitum, Standard laboratory diet SDS Stanrab
- Water: ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): maintained at approximately 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light):12/12






Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
single treatment
Observation period:
8 days
Number of animals:
six
Details on study design:
TEST SITE
- Area of exposure: dorsal area of 25mm2
- % coverage: 25 mm x 25 mm
- Type of wrap if used: gauze pad, covered with "Elastoplast" elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water ( 30°- 40°C)
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- on Day 1 ( approximately 30 minutes after removal of the dressings)
- on Day 2, 3 and 4 (= 24h, 48h and 72h)
- additional observations were made on Days 5 to 8

SCORING SYSTEM:
- Method of calculation: Local dermal irritation was assessed using the prescribed numerical system:

Erythema and eschar formation:

No erythema 0
Very slight erythrema (barely perceptible) 1
well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation:

No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48/72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #4
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Very slight erythrema was observed in a single animal only immediately after the removal of the dressings. By Day 2 very slight to well-defined erythema with or without very slight to slight edema was seen in all animals. Very slight erythema accompanied by very slight edema was observed in all animals on Day 3. All dermal reactions had resolved in three animals by Day 4 and in a further animal by Day 5. In the remaining two rabbits very slight dermal reactions persisted up to and including Day 7.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Table 1: Dermal reactions observed after application of MCPP-P 2-EHE

Rabbit number (# animal)

E = Erythema

O= Oedema

Day

 1*          2         3          4           5         6         7        8

1 (male)

E

O

 0           1         1           0          0          0        0         0

 0           1         1           0          0          0        0         0

 0           1         1           0          0          0        0         0

 0           0         1           0          0          0        0         0

 1           2         1           1          1          1        1         0

 0           1         1           1          1          1        1         0

 0           2         1           0          0          0        0         0

 0           1         1           0          0          0        0         0

 0           1         1           1          0          0        0         0

 0           2         1           0          0          0        0         0 

 0           1         1           1          1          1        1         0

 0           1         1           1          1          1        1         0

2 (male)

E

O

3 (male)

E

O

4 (male)

E

O

5 (male)

E

O

6 (male)

E

O

*Approximately 30 min after removal of the dressing

Interpretation of results:
GHS criteria not met
Conclusions:
MCPP-P 2-EHE showed no skin irritation potential.
Executive summary:

A dermal skin irritation study to assess the skin irritation potential of MCPP-P 2-EHE was performed. The method followed was that described in EPA Pesticide Assessment Guidelines, Subdivision F. Hazard Evaluation: Human and Domestic animals 81-5 Primary dermal irritation (Version 1984). Six rabbits were each administered a single dermal dose of 0.5 mL of the test substance and observed for a maximum of eight days. A single semi-occlusive application of MCPP-P 2-EHE to intact skin for 4 hours elicited very slight to well-defined dermal reactions, while all reactions had resolved by day 8. The mean value for erythema was not higher than 1.3 and the mean value for edema was not higher then 1 (according Draize score).

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:
September 1, 1992 - September 15, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Version / remarks:
EPA FIFRA Subdivision F Guideline 81-4 Primary eye irritation, revised Edition November 1984
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- batch No.of test material: 5007
- sample No.:1505E
- Expiration date of the lot/batch: March 1993

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4°C in the dark
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna U.K. Ltd., Huntingdon, Cambridgeshire, England (5) and 1 from Froxfield U.K. Ltd., Petersfield, Hampshire, England
- Age at study initiation: 11- 14 weeks
- Weight at study initiation: 2.6 to 3.1 kg
- Housing: individually in plastic cages with perforated floors
- Diet: ad libitum (Standard laboratory diet SDS Stanrab Rabbit Diet)
- Water: ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 -70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL placed into the lower everted lid of one eye of each animal.
- the eyelids were then gently held together for one second before releasing


Duration of treatment / exposure:
single
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: eyes were not washed 24 h after treatment

SCORING SYSTEM:
Examination of the eyes was made after 1 hour and 1, 2, 3 days (equivalent to 24, 48 and 72 hours after instillation), 4 and 7 days after instillation

Ocular irritation was assessed using the prescribed numerical system:

Cornea:
opacity: degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of nuermal lustre,
details of iris clearly visible 1*
Easily discernible translucent areas, details of iris slightly obscured 2*
Nacreous areas, no details of iris visible, size of pupil barely discernible 3*
Opaque cornea, iris not discernible through the opacity 4*

Iris:
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal
hyperaemia or injection, any of these or combination of any thereof, iris still
reacting to light (sluggish reaction positive) 1*
No reaction to light, haemorrhage, gross destruction (any or all of these) 2*

Conjunctivae:
Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2*
Diffuse beefy red 3*

Chemosis (lids and/or nictating membranes)
No swelling 0
Any swelling above normal (includes nictating membranes9 1
Obvious swelling with partial eversion of lids 2*
Swelling with lids about half-closed 3*
Swelling with lids more than half-closed 4*

Discharge
No discharge 0
Any amount different from normal (does not include small amounts observed
in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, and considerable area
around the eye 3

*interpreted as a positive effect

TOOL USED TO ASSESS SCORE: handheld lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal#1
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal#1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
animal#1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal#1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal#2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal#2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
animal#2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal#2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal#3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal#3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
animal#3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal#3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal#4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal#4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
animal#4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal#4
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal#5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal#5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
animal#5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal#5
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal#6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal#6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
animal#6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal#6
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 3 days
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Table 1: Ocular reactions observed after instillation of MCPP-P 2-EHE

Rabbit number (#)

Region of the eye

One hour

Days after instillation

Result

Positive (+)

Negative (-)

 

1      2      3      4       7

+

Animal #1 (male)*

Cornea

Density

0

3      2      2      1       0

Iris

0

0      0      0      0       0

Conjunctiva

Redness

2

1      1      1      1       0

Chemosis

1

1      1      0      0       0

Discharge

2

1      1      0      0       0

Animal #2

(female)

Cornea

Density

0

0      0      0      0       0

+

Iris

0

0      0      0      0       0

Conjunctiva

Redness

2

2      1      0      0       0

Chemosis

1

1      0      0      0       0

Discharge

2

1      0      0      0       0

Animal #3

(female)

Cornea

Density

0

0      0      0      0       0

+

Iris

0

0      0      0      0       0

Conjunctiva

Redness

2

2      1      0      0       0

Chemosis

1

1      0      0      0       0

Discharge

2

1      0      0      0       0

Animal #4 (female)

Cornea

Density

0

0      0      0      0       0

+

Iris

0

0      0      0      0       0

Conjunctiva

Redness

2

2      1      0      0       0

Chemosis

1

1      0      0      0       0

Discharge

2

1      0      0      0       0

Animal #5 (female)

Cornea

Density

0

0      0      0      0       0

+

Iris

0

0      0      0      0       0

Conjunctiva

Redness

2

2      1      0      0       0

Chemosis

1

1      0      0      0       0

Discharge

2

1      0      0      0       0

Animal #6 (female)

Cornea

Density

0

0      0      0      0       0

+

Iris

0

0      0      0      0       0

Conjunctiva

Redness

2

2      1      0      0       0

Chemosis

1

1      0      0      0       0

Discharge

2

1      0      0      0       0

Interpretation of results:
GHS criteria not met
Conclusions:
Instillation of MCPP-P 2-EHE into the rabbit eye elicited a positive response in all of the six treated animals according to EPA FIFRA test critaria, which all resolved seven days after instillation.
Executive summary:

A GLP-Study to assess the eye irritation potential of MCPP-P 2-EHE on rabbits was performed. The method followed was that described in EPA Pesticide Assessment Guidelines, Subdivision F. Hazard Evaluation: Human and Domestic Animals 81-4 Primary eye irritation (Version 1984). Six rabbits were each administered a single ocular dose of 0.1 mL of the test item and observed for a maximum of seven days after instillation. The administration into the eye of the rabbit elicited corneal opacification in one animal and mild conjunctival irritation. According to Draize score, only one animal showed a corneal opacity (mean score of 2.3), while mean conjunctival redness, chemosis and iris effects were not scored higher than 1 and all reactions had resolved seven days after instillation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A dermal skin irritation study to assess the skin irritation potential of MCPP-P 2-EHE was performed. The method followed was that described in EPA Pesticide Assessment Guidelines, Subdivision F. Hazard Evaluation: Human and Domestic animals 81 -5 Primary dermal irritation (Version 1984). Six rabbits were each administered a single dermal dose of 0.5 mL of the test substance and observed for a maximum of eight days. A single semi-occlusive application of MCPP-P 2-EHE to intact skin for 4 hours elicited very slight to well-defined dermal reactions, while all reactions had resolved by day 8. The mean value for erythema was not higher than 1.3 and the mean value for edema was not higher then 1 (according Draize score; MCPP-p Task Force 920812D/JEL 73/SE; 1992).

Eye irritation

A GLP-Study to assess the eye irritation potential of MCPP-P 2-EHE on rabbits was performed. The method followed was that described in EPA Pesticide Assessment Guidelines, Subdivision F. Hazard Evaluation: Human and Domestic Animals 81 -4 Primary eye irritation (Version 1984). Six rabbits were each administered a single ocular dose of 0.1 mL of the test item and observed for a maximum of seven days after instillation. The administration into the eye of the rabbit elicited corneal opacification in one animal and mild conjunctival irritation. According to Draize score, only one animal showed a corneal opacity (mean score of 2.3), while mean conjunctival redness, chemosis and iris effects were not scored higher than 1 and all reactions had resolved seven days after instillation (MCPP-p Task Force 920824D/JEL 74/SE; 1992 ).

In conclusion, MCPP-P 2-EHE showed no persistent or classifiable skin or eye irritating effect. All reactions had resolved by 8 days.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The substance is not considered to be classified for skin or eye irritation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.