Registration Dossier

Administrative data

Description of key information

In accordance with Annex VIII, section 8.6.1, column 2 and Annex IX, section 8.6.1, column 1, no testing of oral or dermal repeated dose toxicity is required as inhalation is the most probable exposure pathway.

According to the results of the performed 90-day repeated dose toxicity inhalation study, „2-propanol and 2-butanol production, distn. residues“ does not need to be classified for specific target organ toxicity – repeated exposure.

None of the main components of the „2-propanol and 2-butanol production, distn. residues“ (DSBE, DIPE, SBA, TBA) meets the criteria for a classification as category 1 or 2 Specific Target Organ Toxicity - repeated exposure, as derived from literature values for oral / inhalation repeated dose toxicity, as far as values are known (see table below; all NOAEL (oral) > 100 mg/kg bw/day; all NOAEL (inhalation) > 250 ppmV/6h/day or 1 mg/litre/6h/day). This is in accordance with the results on the substance itself.

Table: Repeated-dose toxicity data for the main components of the reaction mass from the literature

 

Oral

Inhalation

DSBE (1)

NOAEL: 1500 mg/kg/day (from analogue, SBA) (rat, 8-week)

From analogue, SBA: NOAEL: 3500 ppm (maternal toxicity) (rat, 19-day)

NOAEL: >7000 ppm (developmental toxicity) (rat, 19-day)

From analogue, MEK (rat, 90-day): NOAEL 2500 ppm, LOAEL 5000 ppm

DIPE (2)

 

NOAEL: 480 ppm(rat, 90-day)

NOAEC 13800 mg/m³, LOAEC: 7100 ppm (rat, subchronic, 13 weeks, exposure 6 h/day)

SBA (3)

 

NOAEL: 3500 ppm (maternal toxicity) (rat, 19-day)

NOAEL: >7000 ppm (developmental toxicity) (rat, 19-day)

From analogue, MEK (rat, 90-day): NOAEL 2500 ppm, LOAEL 5000 ppm

TBA (4)

Rat, 90-day:

LOAEL = 490 mg/kg-bw/day

NOAEL = 590 mg/kg-bw/day

Mouse, 90-day:

LOAEL = 3940 mg/kg-bw/day

NOAEL = 1590 mg/kg-bw/day

Rat, 2-year:

LOAEL = 180 mg/kg-bw/day

NOAEL = 90 mg/kg-bw

Mouse, 2-year:

LOAEL = 1030 mg/kg-bw/day

NOAEL = 525 mg/kg-bw/day

LOAEL = 3.27 mg/L (rat, mouse, 90-day)

NOAEL = 1.63 mg/L (rat, mouse, 90-day)

 

References:

(1) HIGH PRODUCTION VOLUME (HPV) CHEMICAL CHALLENGE PROGRAM TEST PLAN For sec-Butyl Ether CAS NO. 6863-58-7, Prepared by: ExxonMobil Chemical Company November 28, 2006

(2) ExxonMobil Chemical Company Shell Chemical LP For: American Chemistry Council, lsopropanol Panel, Diisopropyl Ether HPV Task Group December 12, 2005

(3) OECD SIDS Dossier for Butan-2-ol, CAS No.78-92-2, ExxonMobil Biomedical Sciences Inc., 09.01.2002

(4) Robust Summaries for t-Butanol, CAS Number 75-65-0 USEPA HPV Challenge Program Submission April 10, 2002

 

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:

The NOAEC from the 90-day subchronic toxicity inhalation study was selected as a basis for DNEL derivation for systemic health effects.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
11 350 mg/m³
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to the results of the performed 90-day repeated dose toxicity inhalation study, „2-propanol and 2-butanol production, distn. residues“ does not need to be classified for specific target organ toxicity – repeated exposure according to CLP (Regulation EC 1272/2008).