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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Value:
150 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to R.8

AF for difference in duration of exposure:2 (Subchronic study)

AF for other interspecies differences:2.5 (Remaining non-metabolic differences)

AF for intraspecies differences:5 (Workers)

Overall Assessment Factor:25

AF for dose response relationship:
1
Justification:
Starting point is NOAEL
AF for differences in duration of exposure:
1
Justification:
Chronic study
AF for other interspecies differences:
2.5
Justification:
Remaining non-metabolic differences
AF for intraspecies differences:
5
Justification:
Workers
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
6 800 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

According to R.8. Conservative assumption of 1% dermal absorption applied to oral NOAEL value.

AF for interspecies differences (allometric scaling):4 (Rat to human)

AF for other interspecies differences:2.5 (Remaining non-metabolic differences)

AF for intraspecies differences:5 (Workers)

Overall Assessment Factor:100

AF for dose response relationship:
1
Justification:
Starting point is NOAEL
AF for differences in duration of exposure:
1
Justification:
Chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
2.5
Justification:
Remaining non-metabolic differences
AF for intraspecies differences:
5
Justification:
Workers
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The endpoint records reflect data from BABS Acid where available, and in some cases, from the analogue sodium salt of linear alkylbenzene sulfonate (commonly known as LAS) or branched alkylbenzene sulfonate (ABS). LAS is the sodium salt of linear alkylbenzene sulfonic acid with alkyl carbon chain lengths ranging from C10 to C13 and averaging 11.6. The primary structure is a C10 to C13 linear alkyl chain with a para-substituted benzene sulfonic acid sodium salt group attached at any of the secondary alkyl carbon positions. 

The LAS material is a good analogue for read-across for instances where data are available on it but not on BABS Acid. For LAS, the alkyl chain length varies and so specific LAS may be used in some of the testing for which data are provided in this section. When available the specific LAS is identified in the endpoint record and the tables in this chemical safety report. For ease of reading, the general terms LAS, ABS, and BABS Na salt are used in the text.

Selection of the critical DNELs and qualitative descriptors was carried out as part of the hazard assessment. The results of this assessment are shown in the following tables for workers and the general population.

BABS Acid is moderately toxic to laboratory animals in acute oral studies with an LD50 of 520 mg/kg. BABS Acid is corrosive and classified as Skin Corr. 1C and Eye Dam.1 under CLP. No acute inhalation DNEL is necessary because inhalation is not a significant route of exposure. 

DNELs were derived for long-term systemic effects for dermal exposures. In accordance with REACH guidance chapter R.8, the NOAEL of 85 mg/kg bw/day from the three repeated dose studies was used to derive the DNEL. Applying assessment factors to this NOAEL to consider intra- and interspecies sensitivity, differences between workers and general populations, exposure durations, dose-response, and database quality resulted in the derived DNEL.  Thus, the long-term systemic DNEL is 8.5 mg/kg bw/day for the dermal route of exposure for workers.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.48 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Value:
74 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to R.8

AF for difference in duration of exposure:2 (Subchronic)

AF for other interspecies differences:2.5 (Remaining non-metabolic differences)

AF for intraspecies differences:10 (General population)

Overall Assessment Factor:50

AF for dose response relationship:
1
Justification:
Starting point is NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic
AF for other interspecies differences:
2.5
Justification:
Remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
General population
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
6 800 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

According to R.8. Conservative assumption of 1% dermal absorption applied to oral NOAEL value.

AF for difference in duration of exposure:2 (Subchronic)

AF for interspecies differences (allometric scaling):4 (Rat to human)

AF for other interspecies differences:2.5 (Remaining non-metabolic differences)

AF for intraspecies differences:10 (General population)

Overall Assessment Factor:200

AF for dose response relationship:
1
Justification:
Starting point is NOAEL
AF for differences in duration of exposure:
1
Justification:
Chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
2.5
Justification:
Remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
General population
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.43 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
85 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

According to R.8

AF for difference in duration of exposure:2 (Subchronic)

AF for interspecies differences (allometric scaling):4 (Rat to human)

AF for other interspecies differences:2.5 (Remaining non-metabolic differences)

AF for intraspecies differences:10 (General population)

Overall Assessment Factor:200

AF for dose response relationship:
1
Justification:
Starting point is NOAEL
AF for differences in duration of exposure:
2
Justification:
Chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
2.5
Justification:
Remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
General population
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

The endpoint records reflect data from BABS Acid or salt where available, and in some cases, from the analogue sodium salt of linear alkylbenzene sulfonate (commonly known as LAS). LAS is the sodium salt of linear alkylbenzene sulfonic acid with alkyl carbon chain lengths ranging from C10to C13and averaging 11.6. The primary structure is a C10to C13linear alkyl chain with apara-substituted benzene sulfonic acid sodium salt group attached at any of the secondary alkyl carbon positions. BABS Na salt is the sodium salt of branched alkylbenzene sulfonic acid with alkyl chain lengths ranging from C11to C13. ABS is the branched sodium salt analogue of CaDDBS.

The primary difference between the two moieties are the salt – either sodium or calcium, and the alkyl chain - either linear or branched. Given their structural and functional similarities, the LAS material is a good analogue for read-across for instances where data are available on it but not on BABS Acid. For LAS, the alkyl chain length varies and so specific LAS may be used in some of the testing for which data are provided in this section. When available the specific LAS is identified in the endpoint record and the tables in this chemical safety report. For ease of reading, the general terms LAS, ABS, and BABS Na salt are used in the text.

Selection of the critical DNELs and qualitative descriptors was carried out as part of the hazard assessment. The results of this assessment are shown in the following tables for workers and the general population.

BABS Acid is moderately toxic to laboratory animals in acute oral studies with an LD50 of 520 mg/kg. BABS Acid is corrosive and classified as Skin Corr. 1C and Eye Dam.1 under CLP. No acute inhalation DNEL is necessary because inhalation is not a significant route of exposure. 

 

DNELs were derived for long-term systemic effects for dermal exposures. In accordance with REACH guidance chapter R.8, the NOAEL of 85 mg/kg bw/day from the three repeated dose studies was used to derive the DNEL. Applying assessment factors to this NOAEL to consider intra- and interspecies sensitivity, differences between workers and general populations, exposure durations, dose-response, and database quality resulted in the derived DNEL. Thus, the long-term systemic DNEL is 4.25 mg/kg bw/day for the dermal route of exposure for the general population.