Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.55 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
Dose descriptor starting point:
NOAEL
Value:
85 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
189 mg/m³
Explanation for the modification of the dose descriptor starting point:

Conducted using route-to-route extrapolation according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8 (Version 2.1, November 2012).

Starting Dose Descriptor: Repeated Dose Toxicity: Oral - NOAEL = 85 mg/kg bw/d

Correction for Differences in Respiratory Volume (Workers) = 2.63

Correction for Differences in Bioavailability = 0.9

Correction for Light Activity at Work = 0.67

Correction for Differences between Human and Experimental Exposure Conditions (Workers) = 1.4

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 650 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
Dose descriptor starting point:
NOAEL
Value:
85 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
165 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Conducted using route-to-route extrapolation according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8 (Version 2.1, November 2012).

Correction for Differences in Bioavailability: 1384.62

Correction for Differences between Human and Experimental Exposure Conditions (Workers): 1.4

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

For DNEL derivation (long-term systemic for inhalation and dermal), the dose descriptor was based on the results of the repeated dose toxicity study (Yoneyama et al., 1976). Default assessment factors were applied in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8 (Version 2.1, November 2012).

In the key study for repeated dose toxicity (Yoneyama et al. 1976), male and female rats were exposed to LAS in drinking water daily for 9 months. Test doses were 85, 145 and 430 mg/kg bw/d plus the control. Eight to nine animals of each sex were exposed per group. Body weight was suppressed in the highest dose group only. Significant decreases in transaminase activity and renal Na,K-ATPase were seen in the 145 mg/kg bw/d group. No significant haematological or organ weight changes were noted. Based on enzyme activity, the resultant LOAEL and NOAEL values were 145 and 85 mg/kg bw/day, respectively.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.33 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
Dose descriptor starting point:
NOAEL
Value:
85 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
66.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

Conducted using route-to-route extrapolation according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8 (Version 2.1, November 2012).

Starting Dose Descriptor: Repeated Dose Toxicity: Oral - NOAEL = 85 mg/kg bw/d

Correction for Differences in Respiratory Volume (General Population) = 0.87

Correction for Differences in Bioavailability = 0.9

Correction for Differences between Human and Experimental Exposure Conditions (General Population) = 1

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
588 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
Dose descriptor starting point:
NOAEL
Value:
85 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
118 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Conducted using route-to-route extrapolation according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8 (Version 2.1, November 2012).

Correction for Differences in Bioavailability: 1384.62

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.425 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
Dose descriptor starting point:
NOAEL
Value:
85 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
85 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification of the dose descriptor was required.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

For DNEL derivation (long-term systemic for inhalation, dermal and oral), the dose descriptor was based on the results of the repeated dose toxicity study (Yoneyama et al., 1976). Default assessment factors were applied in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8 (Version 2.1, November 2012).

In the key study for repeated dose toxicity (Yoneyama et al. 1976), male and female rats were exposed to LAS in drinking water daily for 9 months. Test doses were 85, 145 and 430 mg/kg bw/d plus the control. Eight to nine animals of each sex were exposed per group. Body weight was suppressed in the highest dose group only. Significant decreases in transaminase activity and renal Na,K-ATPase were seen in the 145 mg/kg bw/d group. No significant haematological or organ weight changes were noted. Based on enzyme activity, the resultant LOAEL and NOAEL values were 145 and 85 mg/kg bw/day, respectively.