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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

The test substance is irritating to the skin of rabbits (OECD TG 404, GLP).

The test substance is mildly irritating to the eyes of rabbits (OECD TG 405, GLP).

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): BPI (Benzophenone imine)
- Analytical purity: 94.8 %
- Lot/batch No.: 11/94 CONTAINER 13
- Physical state: liquid, light yellow
- Storage condition of test material: refrigerator
- Stability under test conditions: proven by reanalysis
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: young adult animals
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet : Kliba-Labordiaet 341 (Klingentalmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%): 30 -70
- Photoperiod (hrs dark / hrs light): 12 / 12 (6.00 pm - 6.00 am dark, 6.00 am - 6.00 pm light)
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin sites of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.5 ml unchanged liquid test substance
Duration of treatment / exposure:
4 hours
Observation period:
15 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The test substance has been covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece, Baiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing: mild detergent (lutrol, lutor/water (1:1))
- Time after start of exposure: 4 hours

SCORING SYSTEM:

ERYTHEMA AND ESCHAR FORMATION VALUE
0: NO ERYTHEMA
1: VERY SLIGHT ERYTHEMA (BARELY PERCEPTIBLE)
2: WELL DEFINED ERYTHEMA
3: MODERATE TO SEVERE ERYTHEMA
4: SEVERE ERYTHEMA (BEET REDNESS) TO ESCHAR FORMATION PREVENTING GRADING OF ERYTHEMA

EDEMA FORMATION VALUE
0: NO EDEMA
1: VERY SLIGHT EDEMA (BARELY PERCEPTIBLE)
2: SLIGHT EDEMA (EDGES OF AREA WELL DEFINED BY DEFINITE RAISING)
3: MODERATE EDEMA (RAISED APPROX. 1 MM)
4: SEVERE EDEMA (RAISED MORE THAN 1 MM AND EXTENDING BEYOND AREA OF EXPOSURE)
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
3.4
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
2.2
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritant / corrosive response data:
The average score (24 - 72 hours) for irritation was calculated to be 3.4 for erythema and 2.2 for edema. Some findings were not reversible in all animals within 15 days after removal of the patches. Intensive scaling was observed on day 8 and day 14. No necrosis was observed

Table 1: IRRITANT RESPONSE DATA FOR EACH INDIVIDUAL ANIMAL AT EACH OBSERVATION TIME:

 Reading  Animal  Erythema  Edema
 1 hour  1  3  3
   2  3  3
   3  3  3
 24 hours  1  4  3
   2  4  3
   3  4  4
 48 hours  1  4  2
   2  3  1
   3  3  2
 72 hours  1  4  2
   2  2  1
   3  3  2
 8 days  1  3  0
   2  2  1
   3  2  1
 15 days  1  2  0
   2  2  1
   3  2  0
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the test conditions chosen and considering the described findings the test substance gives indication of an severe irritant property to the skin.
Executive summary:

The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 mL of the test substance to the intact skin of three white New Zealand rabbits for 4 hours under semi-occlusive dressing. The study was conducted according to OECD TG 404 and GLP. The average score (24 to 72 hours) for irritation was calculated to be 3.4 for erythema and 2.2 for edema. Some findings were not reversible in all animals within 15 days after removal of the patches. Under the test conditions chosen and considering the described findings the test substance gives indication of an severe irritant property to the skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): BPI (Benzophenone imine)
- Analytical purity: 94.8 %
- Lot/batch No.: 11/94 CONTAINER 13
- Physical state: liquid, light yellow
- Storage condition of test material: refrigerator
- Stability under test conditions: proven by reanalysis
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: young adult animals
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet : Kliba-Labordiaet 341 (Klingentalmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12 (6.00 pm - 6.00 am dark, 6.00 am - 6.00 pm light)


Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE:
- Washing: washed out with water
- Time after start of exposure: 24 hours

SCORING SYSTEM:

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

Area of cornea involved (ar):
1 ≥ 0 ; ≤ ¼
2 ≥ ¼ ; < ½
3 ≥ ½; < ¾
4 ≥ ¾

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

Chemosis (sw): Lids and/or nictating membranes (sw)
0 = No swelling.
1 = Any swelling above normal (includes nictating membranes).
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids more than half closed eye

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

Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not include small amounts ob served in inner canthus of normal animals).
2 =Discharge with moistening of lids.
3 =Discharge with moistening of the lids and hairs, and considerable area around the eye

* Table according to OECD Guideline 405 (adopted Feb. 24, 1987) and EEC L 383A, B.5 (Dec. 29, 1992)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
2.2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1.1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
The average score (24 - 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.7 for iris, 2.2 for conjunctivae redness and 1.1 for chemosis. The findings were reversible in all animals within 8 days after application, thus the study was terminated. See table 1.

Table 1: IRRITANT RESPONSE DATA FOR EACH INDIVIDUAL ANIMAL AT EACH OBSERVATION TIME:

 Reading  Animal # Cornea Opacity Iris  Conjunctivae Erythema   Chemosis
1 hour  1  0  0  1  2
   2  0  0  2  2
   3  0  0  2  1
24 hours  1  1  1  3  1
   2  1  1  3  2
   3  1  0  2  2
48 hours  1  1  0  2  0
   2  1  1  3  2
   3  1  1  2  1
 72 hours  1  1  0  1  0
   2  1  1  2  1
   3  1  1  2  1
 8 days  1  0  0  0  0
   2  0  0  0  0
   3  0  0  0  0
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the test conditions chosen and considering the described findings, the test substance is mildly irritating to the eyes.
Executive summary:

The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed in three white New Zealand rabbits, subjected to a single ocular application of 0.1 mL of the test substance on day 0. The study was conducted according OECD TG 405 and GLP.

The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.7 for iris, 2.2 for conjunctivae redness and 1.1 for chemosis. The findings were reversible in all animals within 8 days after application, thus the study was terminated. Symptoms observed and described in the respective obdervation table in detail together with the average score for irritation do not indicate an irritant property of the test substance to the eye.

Under the test conditions chosen and considering the described findings, the test substance is mildly irritating to the eyes.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion

The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 mL of the test substance to the intact skin of three white New Zealand rabbits for 4 hours under semi-occlusive dressing. The study was conducted according to OECD TG 404 and GLP. The average score (24 to 72 hours) for irritation was calculated to be 3.4 for erythema and 2.2 for edema. Some findings were not reversible in all animals within 15 days after removal of the patches. Under the test conditions chosen and considering the described findings the test substance gives indication of an severe irritant property to the skin.

Eye irritation

The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed in three white New Zealand rabbits, subjected to a single ocular application of 0.1 mL of the test substance on day 0. The study was conducted according OECD TG 405 and GLP. The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.7 for iris, 2.2 for conjunctivae redness and 1.1 for chemosis. The findings were reversible in all animals within 8 days after application, thus the study was terminated. Symptoms observed and described in the respective obdervation table in detail together with the average score for irritation do not indicate an irritant property of the test substance to the eye. Under the test conditions chosen and considering the described findings, the test substance is mildly irritating to the eyes.

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 1272/2008.

The test substance was irritating to the skin of rabbits in a study according OECD TG 404 and GLP and mildly irritating to the eyes of rabbits ina a GLP-compliant OECD TG 405 study. Therefore, the test is classified for skin irritation Cat. 2 and eye irritation Cat. 2 under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.