Registration Dossier

Administrative data

Description of key information

Skin: 
The key read-across study and all supporting studies gave similar results and so the skin irritation key value was the same for all (non-irritating). This is considered to apply for the registration substance due to the structural similarities, and the presence of oil would not impact the result. The substances were determined to be non-irritating to the skin. Based on these outcomes, classification as a skin irritant is not required according to the CLP Regulation EC 1272/2008, and also Directive 67/548/EEC (Dangerous Substances Directive).
Eye:
The key read-across study and all supporting studies gave similar results and so the eye irritation key value was the same for all (non-irritating). This is considered to apply for the registration substance due to the structural similarities, and the presence of oil would not impact the result. The substances were determined to be non-irritating to the eyes. Based on these outcomes, classification as an eye irritant is not required according to the CLP Regulation EC 1272/2008, and also Directive 67/548/EEC (Dangerous Substances Directive).

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

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

Additional information

There are no available data for this endpoint for CAS: 96152-43-1, however suitable studies from supporting, structurally similar substances have been used as for read-across purposes to address the following endpoints (for read-across justification see section 13).

Skin:

The following studies have been used to address this endpoint:

- The Brorby, 1986 key study (Chevron report number: SOCAL 2503) was comparable to the OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and was conducted to GLP. Although there was no guideline stated, the study predates OECD 404 and basic scientific principles are similar to recognised guidelines. The reliability rating for this study is 1, however this is being used as read across from a supporting substance as there was no available data to fulfil this endpoint for the test material and so the reliability rating will be reduced to 2, according to the criteria of Klimisch, 1997. The study is being used as read across from a structurally similar substance (Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts; CAS No. 122384-86-5/68784-25-8). The material was determined to be non-irritating in accordance with the CLP Regulation EC 1272/2008, and also Directive 67/548/EEC (Dangerous Substances Directive). .

There are also the following supporting studies included for this endpoint:

- The Hirose et al study, 1986 (Chevron report number: SOCAL 2433A) was identical in methodology to the key study (Brorby, 1986). Although there was no guideline stated, the study predates OECD 404 and basic scientific principles are similar to recognised guidelines.

The reliability rating for this study is 1, however this is being used as read across to a supporting substance as there was no available data to fulfil this endpoint for the test material and so the reliability rating will be reduced to 2, according to the criteria of Klimisch, 1997. The study is being used as read across to a structurally similar substance (Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts; CAS No. 122384-86-5/68784-25-8).

The primary irritation score was 1.3. The mean value of the scores for erythema and edema formation for 24, 48 and 72 hours was calculated to be 0.2 and so will not be classified as irritating in accordance with the CLP Regulation EC 1272/2008, and also Directive 67/548/EEC (Dangerous Substances Directive

- The Meyding et al study, 1962a (Hazleton report number: 20-0169-33) was not conducted according to a recognised guideline or GLP. There are also significant deviations affecting this study such as the test substance being left on for 24 hours rather than 4 hours as suggested in recognised guidelines, and also the test material was not removed with an appropriate solvent after exposure. The study was therefore considered to have a reliability rating of 3, according to the criteria of Klimisch, 1997.

The study is being used as read across to a structurally similar substance (Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased CAS No. 122384-87-6/68784-26-9).

The test material produced a moderate degree of irritation characterized by erythema and edema involving both intact and abraded skin areas. Little improvement was observed at the 72-hour observation for although the edema had significantly subsided, erythema increased and substantial drying of the skin occurred. The primary dermal irritation index of the test material was 3.8.

The test material could not be classified as only 24 and 72 hour readings were available.

- The Meyding et al study, 1962b (Hazleton report number: 20-0169-33) was not conducted according to a recognised guideline or GLP. There are also significant deviations affecting this study such as the test substance being left on for 24 hours rather than 4 hours as suggested in recognised guidelines, and also the test material was not removed with an appropriate solvent after exposure. The study was therefore considered to have a reliability rating of 3, according to the criteria of Klimisch, 1997.

The study is being used as read across to a structurally similar substance (Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts; CAS No. 122384-86-5/68784-25-8).

The primary dermal irritation index of the test material is 6.2.

The test compound produced a severe reaction on both the intact and abraded surfaces. Maximum scores for edema and erythema were frequently observed; the irritation had not subsided appreciably by the 72-hour observation period.

The test material could not be classified as only 24 and 72 hour readings were available.

- The Brett, 1975 study was conducted according to the Federal Hazardous Substance Act (16 CFR 1500). A reliability rating of 3 was assigned according to the criteria of Klimisch, 1997 due to the following deviations: The study employed a 24 hour exposure instead of the standard 4 hour exposure. No details of test material removal from the skin. The information was obtained from the peer reviewed, 2006 OECD SIDS dossier due to the original report being unavailable.

The study is being used as read across to a structurally similar substance (Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased).

The test material could not be classified as only 24 and 72 hour readings were available, however it was considered not irritating according to the FSHA.

- The Exxon Biomedical Sciences study, 1992 was comparable to the OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and was conducted to GLP.

The test substance was removed using water and due to the low solubility of the test material it is unlikely that this method will have fully removed the test material from the test sites, therefore a reliability rating of 3, according to the criteria of Klimisch, 1997 was assigned.

The study is being used as read across to a structurally similar substance (Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased CAS No. 122384-87-6/68784-26-9).

primary irritation index = 2.42.

The mean value of the scores for erythema and edema formation for 24, 48 and 72 hours was calculated to be 1.1.

- The Exxon Biomedical Sciences study, 1986 was comparable to the OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and was conducted to GLP.

The test substance was removed using water and due to the low solubility of the test material it is unlikely that this method will have fully removed the test material from the test sites, therefore a reliability rating of 3, according to the criteria of Klimisch, 1997 was assigned.

The study is being used as read across to a structurally similar substance (Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased CAS No. 122384-87-6/68784-26-9).

primary irritation index = 5.33.

The mean value of the scores for erythema and edema formation for 24, 48 and 72 hours was calculated to be 2.6 however this study was not considered reliable and so will not be taken into account when classifying the substance.

Eye

The following studies have been used to address this endpoint;

- The Kern, 2000 (key) study (Report number: WIL-168178) was conducted to the OECD Guideline 405 (Acute Eye Irritation / Corrosion) and GLP. The reliability rating for this study is 1, however this is being used as read across from a supporting substance as there was no available data for this endpoint for the test material and so the reliability rating will be reduced to 2, according to the criteria of Klimisch, 1997. The study is being used as read across from a structurally similar substance (Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased CAS No. 122384-87-6/68784-26-9). The results of the study were non-irritating, and this is the basis for classification decisions for the registration material.

The other supporting studies available are as follows:

- The Brorby et al study, 1986 (Chevron report number: SOCAL 2325) was not considered the key study as there was no guideline stated and the study predates OECD 405, but basic scientific principles look comparable to recognised guidelines. The reliability rating for this study is 1, however this is being used as read across to a supporting substance as there was no available data to fulfil this endpoint for the test material and so the reliability rating will be reduced to 2, according to the criteria of Klimisch, 1997. The study is being used as read across from a structurally similar substance (Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts; CAS No. 122384-86-5/68784-25-8). T

he mean value of the scores for cornea opacity, iris lesions, redness & oedema of the conjuctivae, for 24, 48 and 72 hours was calculated and was considered to be non-irritating in accordance with the CLP Regulation EC 1272/2008, and also Directive 67/548/EEC (Dangerous Substances Directive).

- The Exxon Biomedical Sciences study, 1984 was comparable to the OECD Guideline 405 (Acute Eye Irritation / Corrosion).

The reliability rating for this study is 1, however this is being used as read across to a supporting substance as there was no available data to fulfil this endpoint for the test material and so the reliability rating will be reduced to 2, according to the criteria of Klimisch, 1997. The study is being used as read across from a structurally similar substance (Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased CAS No. 122384-87-6/68784-26-9).

Ocular instillation of the test material elicited only conjunctival responses, including redness, chemosis and discharge. All animals were clear of irritation by the Day 7 observation.

- The Meyding et al study, 1962b (Hazleton report number: 20-0169-33) was not considered the key study as it was conducted less recently than the above key study and was not conducted according to a recognised guideline or GLP. Methods and results were reported. The study was considered to have a reliability rating of 4, according to the criteria of Klimisch, 1997 as observations were not carried out for long enough to enable revesibility of irritation and although methods and results were reported the conjunctivae scores were combined in the results and therefore it was not possible to classify according to current labelling guides and so this study was considered unassignable.

The study is being used as read across from a structurally similar substance (Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts; CAS No. 122384-86-5/68784-25-8).

The test material produced a significant degree of eye irritation in rabbits which has not completely subsided within 72 hours following instillation. The test material could not be classified as information was limited.

- The Meyding et al study, 1962a (Hazleton report number: 20-0169-33) was not considered the key study as it was conducted less recently than the above key study and was not conducted according to a recognised guideline or GLP. Methods and results were reported. The study was considered to have a reliability rating of 4, according to the criteria of Klimisch, 1997 as observations were not carried out for long enough to enable revesibility of irritation and although methods and results were reported the conjunctivae scores were combined in the results and therefore it was not possible to classify according to current labelling guides and so this study was considered unassignable.

The test material produced a significant degree of eye irritation in rabbits which has not completely subsided within 72 hours following instillation. The test material could not be classified as information was limited.

- The Brett, 1975 study was conducted according to the Federal Hazardous Substance Act (16 CFR 1500.42). A reliability rating of 4 was assigned according to the criteria of Klimisch, 1997 due to the following deviations: The information was obtained from the peer reviewed, 2006 OECD SIDS dossier due to the original report being unavailable. The study is being used as read across to a structurally similar substance (Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased).

The test material could not be classified according to the dangerous substances directive, 67/548/EEC or in accordance with the CLP Regulation EC 1272/2008 as no individual animal data was available, however it was considered not irritating according to the FSHA. Mean draize score = 9.0

Other irritation studies do exist for members of this Category, but have not been included here as they do not provide any additional or different information beyond what is already provided, and in addition in most cases it is difficult to derive actual concentrations used for testing.

Justification for classification or non-classification

Skin:

The results chosen for skin irritation did not meet the criteria set out in Directive 67/548/EEC and also Regulation (EC) 1272/2008, therefore classification for skin irritation was not considered to be necessary.

Eye:

The results chosen for eye irritation did not meet the criteria set out in Directive 67/548/EEC and also Regulation (EC) 1272/2008, therefore classification for eye irritation was not considered to be necessary.