Phenol, dodecyl-, branched, sulfurized

Endpoint summary

Description of key information

Oral toxicity: 
The key read-across study and indeed all of the supporting information gave the same result.  For this endpoint the LD50 is considered to be >5000 mg/kg. This result is applicable for the registration substance once it has been adjusted for the presence of oil, due to the structural similarities and category approach being used. The oil presence in the tested sample is 50%, hence the LD50 adopted for the registration material is 2500mg/kg. 
Dermal toxicity:
In the key study for dermal exposure (Brorby, 1986; Report number: SOCAL 2327) there was no mention of what guideline was followed, however the methodology suggests that it was conducted similarly to OECD 402. The study was conducted in line with GLP. A reliability rating of 2 was applied for readacross, according to the criteria of Klimisch, 1997. This was considered the most reliable study. The acute dermal LD50 of the test material was considered to be >5 g/kg when administered as an 80% suspension in mineral oil (so the true tested sample LD50 >4 g/kg test material). The sample tested claims to be 100% pure (no oil) and this is presumably why it had to be diluted in mineral oil for administration. Hence this result can be used as is for the registration material. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Quality of whole database:

The majority of the studies available are old (20yrs +) and while there were initially some 12-13 studies potentially available for members of the category, many have been removed from the assessment on the grounds of either limited data presented, or poor reporting, or other issues. Only those with reasonable quality and which support a consistent characterisation have been retained, however almost all studies regardless of quality showed a similar pattern and the LD50 chosen is broadly similar in all.
The LD50 chosen (5g/kg) is adjusted for the 50% presence of oil to give an LD50 for the registration material of 2500mg/kg.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

835 mg/m³

Quality of whole database:

Only one study available, and insufficient information from this study to adequately characterise hazard. However further characterisation not justified as properties of material do not support there being any potential for exposure via this route. The study can be used to derive a NOAEC which can be converted to apply to the Registration material (/50%) and then be used for DNEL derivation, however the value of the results is limited.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 000 mg/kg bw

Quality of whole database:

The LD50 for the key study was nominally 5000mg/kg bw however it was administered in a solution of 80% mineral oil, hence the true LD50 for the tested substance was considered to be 4000mg/kg.

Additional information

There are no available data for this endpoint for CAS: 96152-43-1, however it is likely to behave similarly to the other materials in the category therefore studies from these supporting, structurally similar substances have been used as for read-across purposes to address the following endpoints.

Oral Toxicity

The following key study has been used to address this endpoint:

- In the Brorby, 1986 study (Report number: SOCAL 2326) there was no mention of what guideline was followed, however the methodology suggests that it was conducted similarly to OECD 401. The study was conducted in line with GLP. A reliability rating of 1 according to the criteria of Klimisch, 1997. This was in fact considered to be the most reliable study. 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. This study is being used as read across from Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased CAS No. 122384-87-6/68784-26-9.

There are also the following supporting studies for this endpoint:

- The Costello BA, Murray RB & Moore study, 1983 (Biosearch report number: 83-3824A) was not considered a key study as it was conducted less recently than the above key study and was conducted according to CFR 1500.3 Federal Hazardous Substances Act, rather than an OECD guideline. The study was considered to have a reliability rating of 2, according to the criteria of Klimisch, 1997. This study is being used as read across from Phenol, tetrapropenyl-, sulfurized, calcium salts CAS No. 68855-45-8.

The test article, when administered to 5 male and 5 female rats, had an acute oral LD50 of >5000 mg/kg.

- The Costello BA, Murray RB & Moore study, 1983 (Biosearch report number: 83-3809A) was conducted less recently than the above key study and was conducted according to CFR 1500.3 Federal Hazardous Substances Act, rather than an OECD guideline. The study was considered to have a reliability rating of 2, according to the criteria of Klimisch, 1997. This study is being used as read across from Phenol, tetrapropenyl-, sulfurized, calcium salts CAS No. 68855-45-8. The test article, when administered to 5 male and 5 female rats, had an acute oral LD50 of >5000 mg/kg.

- The Meyding et al study, 1962a (Hazleton report number: 20-0169-33) was conducted less recently than the more robust key studies and was not conducted according to a recognised guideline or GLP. Satisfactory methods and results are, however, presented so the study was considered to have a reliability rating of 2, according to the criteria of Klimisch, 1997.

This study is being used as read across from Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased CAS No. 122384-87-6/68784-26-9. The acute oral LD50 of the test material for male albino rats is greater than 16.1 g/kg of body weight.

- The Meyding et al study, 1962b (Hazleton report number: 20-0169-33) was conducted less recently than the above key studies and was not conducted according to a recognised guideline or GLP. Again though, satisfactory methods and results are presented. The study was considered to have a reliability rating of 2, according to the criteria of Klimisch, 1997. This study is being used as read across from Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased CAS No. 122384 -86 -5/68784-26-9. The acute oral LD50 of the test material for male albino rats is greater than 19.3 g/kg of body weight.

All studies support the selection of the 5000mg/kg LD50 for the materials tested. This is then adjusted for the presence of oil to provide an LD50 of 2500mg/kg for the Registration material.

Dermal Toxicity

- In the key study for dermal exposure (Brorby, 1986 study,Report number: SOCAL 2327) there was no mention of what guideline was followed, however the methodology suggests that it was conducted similarly to OECD 402. The study was conducted in line with GLP. 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. This study is being used as read across from Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased CAS No. 122384-87-6/68784-26-9. The acute dermal LD50 of the test material was considered to be >5 g/kg when administered as an 80% suspension in mineral oil (>4 g/kg test material). This result is also considered to be directly applicable (as material is 100% and no oil) for the Registration material.

There are also the following supporting studies for this endpoint:

- The Meyers, 1986 study was not considered the key study as it was conducted less recently than the above key study, was conducted on abraded skin and the information was obtained from the peer reviewed, 2006 OECD SIDS dossier due to the original report being unavailable. A reliability rating of 4 was assigned according to the criteria of Klimisch, 1997. This study is being used as read across from Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased CAS No. 122384-87-6/68784-26-9.

In an acute dermal toxicity study with the test material a single limit dose of 2.0 g/kg was applied to the abraded skin of five male and five female rabbits for 24 hours. There were no deaths, and no signs of systemic toxicity were observed during the 14-day observation period. The acute dermal LD50 was > 2.0 g/kg.

- 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. Satisfactory methods and results are presented. The study was considered to have a reliability rating of 2, according to the criteria of Klimisch, 1997.

This study is being used as read across from Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased CAS No. 122384-87-6/68784-26-9. The acute dermal LD50 of the test material for rabbits is greater than 15 g/kg of body weight.

- 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. Satisfactory methods and results are presented. The study was considered to have a reliability rating of 2, according to the criteria of Klimisch, 1997.

This study is being used as read across from Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased CAS No. 122384-87-6/68784-26-9. The acute dermal LD50 of the test material for rabbits is greater than 15 g/kg of body weight.

Inhalation Toxicity

- In a supporting study for inhalation exposure (Rittenhouse et al, 1985, Report number: SOCAL 2323) there was no mention of what guideline was followed, however the methodology suggests that it was conducted similarly to OECD Guideline 403 (Acute Inhalation Toxicity). The study was conducted in line with GLP. A reliability rating of 2 according to the criteria of Klimisch, 1997.

The study cannot be used to assign classification to the substance according to the current EU criteria as the animals were exposed for only 1 hour as opposed to the 4 hour described in Directive 67/548/EEC. There were no signs of mortality during the study and consequently the LC50 was determined to be > 1.67 mg/L (males and females).

In accordance with column 2 of REACH Annex VIII, section 8.5.2, it is considered justifiable to omit testing via inhalation. The substance only exists in liquid form and it will not be aerosolized in its normal use pattern and does not exist as small particles or droplets. As such testing via the inhalation route is not considered appropriate for this substance.

Justification for classification or non-classification

Oral:

The key toxicity value chosen for acute toxicity via the oral route was higher than the criteria adopted for classification by the CLP Regulation EC 1272/2008, and also than those for Directive 67/548/EEC (Dangerous Substances Directive). Therefore classification for acute oral toxicity is not considered to be necessary.

Dermal:

The key toxicity value chosen was higher than the criteria adopted for classification by the CLP Regulation EC 1272/2008, and also than those for Directive 67/548/EEC (Dangerous Substances Directive). Therefore classification for acute dermal toxicity is not considered to be necessary.