4,4'-Isopropylidenediphenol, ethoxylated

Endpoint summary

Description of key information

The skin irritation gave mean erythema scores for both animals (24, 48 and 72 hours) were 0.7 -1, and a mean edema score for both animals (24, 48 and 72 hours) was 0. The test substance is not classified as a skin irritant according to EU CLP. In the eye irritation test the mean conjuctivae score was 0.7, the mean cornea score was 0, the mean iris score was 0 and the mean chemosis score was 0 (all at 24, 48 and 72 hours) The test substance is not classified as an eye irritant according to EU CLP.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(partly limited documentation, e.g. no analytical characterisation of the test substance)

Principles of method if other than guideline:

Standardized test method (BASF-Test): The test substance was applied to a 2.5 x 2.5 cm application site of two white Vienna rabbits for 20 h under occlusive conditions. The skin was intact and shaved. After the application time, the skin was washed with water containing a mild detergent. Animals were observed for 5 or 6 days. Findings were recorded after 24, 48 and (for one animal) after 72 hours and at the end of the observation period. Descriptive scores of the raw data have been converted to Draize numerical scores, as recommended by the current OECD 404 Guideline.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS

Source: Gaukler
Weight at study initiation: 2.86 kg (mean)
Diet: ad libitum
Water: ad libitum

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of same animal

Amount / concentration applied:

1 mL

Duration of treatment / exposure:

The test substance was applied for 1 min, 5 min, 15 min and 20 h

Observation period:

5 or 6 days

Number of animals:

2 animals

Details on study design:

TEST SITE

Area of exposure: 2.5 cm x 2.5 cm
Type of wrap if used: occlusive


REMOVAL OF TEST SUBSTANCE

Washing: yes, with water containing a mild detergent (Lutrol)
Time after start of exposure: 1 min, 5 min, 15 min, 20 h


SCORING SYSTEM: Draize scoring system, as recommended by the OECD Testing Guideline 404

Irritation parameter:

erythema score

Remarks:

(20 h exposure)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Remarks:

(20 h exposure)

Basis:

animal #2

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritation parameter:

edema score

Remarks:

(20 h exposure)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: no edema observed

Irritation parameter:

edema score

Remarks:

(20 h exposure)

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

other: no edema observed

Irritant / corrosive response data:

Treatment 20 hours: Very slight signs of irritation (erythema score 1) were observed at the 24 and 48 hour reading time point in both animals. Effects were reversible within 72 hours in animal #1, whereas 72 hours reading time point is missing in animal #2. None of the animals displayed edema.

Treatment 1 min / 5 min / 15 min: no erythema or edema observed until the end of the observation period (48 and 72 hours, respectively).

Table 1: Mean erythema score animal #1 / animal #2 after 24, 48 and 72 h (72 h reading time point is missing in animal #2)

Exposure duration	24 h	48 h	72 h	Effect reversible after
20 h	1/1	1/1	0/-	72 h / 5 d

 

Mean score, animal #1 (24 – 48 – 72 h): 0.7

Mean score, animal #2 (24 – 48 h): 1

Interpretation of results:

GHS criteria not met

Conclusions:

The mean erythema scores for both animals (24, 48 and 72 hours) were 0.7 -1, and the mean edema score for both animals (24, 48 and 72 hours) was 0. The test item is therefore classified as “non-irritant” in accordance with EU CLP 1272/2008 Regulation.

Executive summary:

In a primary dermal irritation study (equivalent to OECD guideline 404),  1 mL of the test substance was applied in an occlusive cover to the clipped skin of Vienna white rabbits (n= 2) for 20 hours followed by 5-6 days observation period. The mean erythema scores for both animals after 24, 48, and 72 hours were 0.7 - 1, and the mean oedema score for both animals after 24, 48 and 72 hours was 0. Based on the results, the test substance is not classified as a skin irritant according to the EU Classification, Labelling, and Packaging (CLP) criteria.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(no details about the test substance; 50 µl instead of 100 µl test substance instilled, eyes were not washed out.)

Principles of method if other than guideline:

Standardized test method (BASF-Test): 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS

Source: Gaukler
Weight at study initiation: 2.05 kg (mean)
Diet: ad libitum
Water: ad libitum

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent eye served as control treated with NaCl.

Amount / concentration applied:

TEST MATERIAL

Amount(s) applied (volume or weight with unit): 50 µL

Duration of treatment / exposure:

Single application (not washed out)

Observation period (in vivo):

72 h (study was interrupted after 72 h due to reversibility of observed effects)

Number of animals or in vitro replicates:

2 animals

Details on study design:

SCORING SYSTEM: Draize scoring system, as recommended by the OECD Testing Guideline 405

TOOL USED TO ASSESS SCORE: fluorescein (at the end of exposure period)

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal #1 and #2)

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(animal #1 and #2)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Remarks:

(animal #1 and #2)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(animal #1 and #2)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Other effects:

No other findings were observed.

Table 1: Summary results

Findings animal #1 / #2:

Time	Redness
10 min	1 / 1
1 h	1 / 1
3 h	1 / 1
24 h	1 / 1
48 h	1 / 1
72 h	0 / 0
Mean (24 – 48 – 72 h)	0.7 / 0.7

 

Interpretation of results:

GHS criteria not met

Conclusions:

The mean conjuctivae score was 0.7, the mean cornea score was 0, the mean iris score was 0 and the mean chemosis score was 0 (all at 24, 48 and 72 hours) The test substance is not classified as an eye irritant according to EU CLP Regulation criteria.

Executive summary:

In a primary eye irritation study (equivalent to OECD Guideline 405), the test substance was administered undiluted at a dose of 50 µL to one eye of Vienna White rabbits (n=2), the adjacent eye served as a control treated with NaCl. The treated eye of each rabbit was scored for irritation at 24- 48- and 72-hours following test item administration.  According to the study protocol, treated eyes were examined 72 hours after dosing. Irritation was scored according to OECD guideline 405 and to the criteria of Draize.

The mean conjunctivae score was 0.7, the mean cornea score was 0, the mean iris score was 0 and the mean chemosis score was 0 (all at 24, 48 and 72 hours). In this study, the test substance was not irritating to the eyes of rabbits. Thus, based on this result, the classification of the test substance as an eye irritant is not warranted according to the EU CLP Regulation 1272/2008 criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There was no skin and eye irritation/corrosion data available with the target substance. Thus, the main constituent of the target substance BPA-2EO was used in a read-across approach to assessing the skin and eye irritation/corrosion potential of the target substance.

In a primary dermal irritation study (equivalent to OECD guideline 404), 1 mL of the test substance was applied under occlusive condition to the skin of Vienna white rabbits (n= 2). The mean erythema scores for both animals after 24, 48, and 72 hours were 0.7 - 1, and the mean oedema score for both animals after 24, 48 and 72 hours was 0.

In a primary eye irritation study (equivalent to OECD Guideline 405), 50 µL of the test substance was administered undiluted into one eye of Vienna White rabbits (n=2), the adjacent eye served as a control treated with NaCl. The mean conjunctivae score was 0.7, the mean cornea score was 0, the mean iris score was 0 and the mean chemosis score was 0 (all at 24, 48, and 72 hours)

In conclusion, based on the available data, the target substance is not a skin and eye irritant, therefore the classification of the target substance as a skin and eye irritant is not warranted according to the criteria of the EU CLP Regulation 1272/2008.

Justification for classification or non-classification

In conclusion, based on the available data, the target substance is not a skin and eye irritant, therefore the classification of the target substance as a skin and eye irritant is not warranted according to EU CLP Regulation 1272/2008.