Reaction mass of Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1) and Amines, C10-14-branched and linear alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-) and Amines, C10-14-branched and linear alkyl, [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)

Endpoint summary

Description of key information

Results for skin irritation / corrosion were based on two UVCB substances of which the constituents show high structural similarity to the target substance (EC 943-133-8).

In an OECD 439 study, CAS 85029-58-9 was found to be not irritating to the skin.

In an in vivo study, CAS 84961-40-0 was found to be not irritating to the skin.

Results for eye irritation were based on three UVCB substances of which the constituents show high structural similarity to the target substance (EC 943-133-8).

In an OECD 492 study, CAS 85029-58-9 was found to be not irritating to the eye.

In an in vivo study, CAS 85029-59-0 was found to be not irritating to the eye.

In an in vivo study, CAS 84961-40-0 was found to be not irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

Please refer to chapter 13 for the read-across justification.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Remarks:

Result read-across source CAS No. 84961-40-0

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

Result read-across source CAS No. 84961-40-0

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Because of the colour of the substance. Result read-across source CAS No. 84961-40-0

Irritation parameter:

other: overall irritation

Remarks:

back

Basis:

mean

Time point:

other: 24 h and 8 d

Remarks on result:

not determinable

Remarks:

Result read-across source CAS No. 85029-59-0

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

Please refer to chapter 13 for the read-across justification.

Reason / purpose for cross-reference:

read-across source

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

mean

Value:

101.6

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

Result read-across source CAS No. 85029-58-9

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation, other

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to chapter 13 for the read-across justification.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

other: tissue viability

Run / experiment:

mean

Value:

108.2

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

Result read-across source Cas No. 85029-89-9

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks:

72 hours last observation time point

Remarks on result:

other: Result read-across source CAS No. 84961-40-0

Irritation parameter:

cornea opacity score

Basis:

animal: #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

Result read-across source CAS No. 84961-40-0

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Remarks:

Result read-across source CAS No. 84961-40-0

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #3

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Result read-across source CAS No. 84961-40-0

Irritation parameter:

conjunctivae score

Basis:

animal: #2, #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Remarks:

Result read-across source CAS No. 84961-40-0

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks:

72 hours last observation time point

Remarks on result:

other: Result read-across source CAS No. 84961-40-0

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Result read-across source CAS No. 84961-40-0

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

Result read-across source CAS No. 84961-40-0

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Result read-across source CAS No. 85029-59-0

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Remarks:

Result read-across source CAS No. 85029-59-0

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No substance-specific data on the skin and eye irritation of the substance (EC 943-133-8) are available. However, according to Article 13 of legislation EC1907/2006, in case no appropriate animal studies are available for assessment information should be generated whenever possible by means other than vertebrate animal tests, i. e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across. CAS No. 85029-58-9, CAS No. 84961-40-0 and CAS No. 850-59-0 are components of the target substance EC 943-133-8. Therefore, the toxicological behaviour of EC 943-133-8 is expected to be similar to that of CAS No. 85029-58-9, CAS No. 84961-40-0 and CAS No. 85029-59-0.

Skin irritation

CAS No. 85029-59-0

The skin irritating potential of CAS No. 85029-59-0 was tested using one male and one female Vienna White rabbit (BASF, 1972). A 50% solution was applied using the patch method (on the back) or using a swab (on the ear). After an exposure period of 20 hours the patch was removed from the back. Signs of irritation were checked after 24 hours and 8 days. No signs of irritation were observed after 24 hours, although redness of the skin could not be assessed due to the colour of the test substance. After 8 days, no signs of irritation were found. This study was considered to be inconclusive due to the staining of the skin not allowing to discriminate irritation.

CAS No. 85029-58-9

Skin irritation of CAS No. 85029-58-9 was assessed in an in an in-vitro skin irritation study (BASF, 2016) performed according to the OECD guideline No. 439, in which the EpiDermTM test method was employed. Human skin cells derived from reconstructed human epidermis tissue containing normal human keratinocytes were used for the test system. Sterile PBS was used a negative control and 5% (w/v) sodium dodecyl sulfate (SDS) in water was used as a positive control. Tissues were washed 1 h after start of application and then placed into the incubator at 37°C for 24 ± 2 hours. After that tissues were transferred into new 6-well plates pre-filled with 0.9 mL of fresh medium and placed into the incubator for additional 18 ± 2 hours post-incubation period. The test methods was performed in at least 3 tissue replicates. In case of equivocal results a second or a third test should be performed. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test-substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. Based on the available information, the test item is not determined to cause irritation to skin.

 

CAS No. 84961-40-0

The skin irritating potential of the CAS No. 84961-40-0 was tested using four male and two female Vienna White rabbits (BASF, 1981). A 50% solution (0.5g) was applied (exposure area of 2.5 x 2.5 cm). Signs of irritation were checked after 24, 48, 72 hours and 8 days after application. Following sacrifice, all animals were subjected to (histo)pathological examination. The oedema scores was determined to be 0.33 for one animal, for all the other animals it was considered to be 0. The effects observed in one animal were fully reversible within 48 hours of exposure. The erythema score could not be determined, because redness of the skin was not determinable due to the colour of the substance. After 3 days, no signs of irritation were found. Based on this data, the substance is considered not-irritating to the skin.

 

Eye irritation

CAS No. 85029-59-0

The eye irritating potential of CAS No. 85029-59-0 was tested using one male and one female Vienna White rabbit (BASF, 1972). The test substance was applied undiluted (50 mg) to the eye. Signs of irritation were checked after 1 hour, 24 hours and 8 days. After 1 hour, the eyes appeared slightly red, although the reddish/brownish colour of the test substance was observed as well. After 24 hours, the eye of only one animal was slightly red. After 8 days, no signs of irritation were found. Based on this data, the substance is considered not-irritating to the eyes.

CAS No. 85029-58-9

The eye irritating potential of CAS No. 85029-58-9 was assessed using an in-vitro eye irritation testing method (BASF, 2016) performed according to the OECD guideline No. 492, in which the EpiOcularTM test method was employed. The ocular irritation potential was assessed by a single topical application of ca. 50 μL bulk volume (about 12 mg) of the undiluted test substance to a reconstructed three dimensional human cornea model. 2 EpiOcularTM tissues were incubated with the test substance for 6 h followed by an 18-h post- incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test-substance treated epidermal tissues is compared to that of negative control tissues. The ratio of the values indicates the relative tissue viability. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is ≤ 60%. Based on the available information, the test item is not considered to be irritating to the eye.

 

CAS No. 84961-40-0

The eye irritating potential of CAS No. 84961-40-0 was tested using Vienna White rabbits (Gaukler), five males and one female (BASF, 1981). The test substance was applied undiluted (11 mg) to the eye. Signs of irritation were noted after 24, 48 and 72 hours. The mean (24-72 h) cornea opacity score was determined to be 0.33 for one animal and 0.0 for the other five animals. The mean (24-72h) conjuctivae score was determined to be 0.66, 0.0, 0.66, 0.0, 0.66, and 0.33 for animal 1, 2, 3, 4, 5, and 6, respectively. The mean (24-72 h) iris and chemosis score were determined to be both 0.0 for all animals. Reversibility could not be determined because observations were only performed until the 72 hour time point. Based on the available data, the substance is considered not-irritating to the eyes.

Justification for classification or non-classification

Based on the results of the available studies, classification is not warranted for skin and eye irritation in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.