2-(2,4-diaminophenoxy)ethanol dihydrochloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: route to route extrapolation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Study performed according to OECD guideline 401 and in compliance to GLP.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(2,4-diaminophenoxy)ethanol dihydrochloride

EC Number:

266-357-1

EC Name:

2-(2,4-diaminophenoxy)ethanol dihydrochloride

Cas Number:

66422-95-5

Molecular formula:

C8H12N2O2.2ClH

IUPAC Name:

2-(2,4-diaminophenoxy)ethan-1-ol dihydrochloride

Details on test material:

Test item : 2-(2,4-diaminophenoxy)ethanol dihydrochloride
EC number : 266-357-1
Batch number : 7
Purity : >98%

Test animals

Species:

rat

Sex:

male/female

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: LD50 calculated from oral data

Effect level:

>= 45 450 mg/kg bw

Based on:

test mat.

Remarks on result:

other: calculated from oral data

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

LD50 calculated dermal: 45 450 mg/kg bw

Executive summary:

For level 10-100 tpy, under REACh, a second route, after the oral should be tested for the acute toxicity: inhalation or dermal route. The dermal route should be considered for the second route of exposure under REACh. Since 2009, the performance of animal tests for those chemicals which are intended to be used in cosmetic products (like this hair dye) is not any longer allowed in the EU. To avoid any negative impact on the intentional use of this chemical, to avoid unnecessary additional animal tests and due to the unlikelihood to get more severe labelling on acute toxicity, any additional testing on acute toxicity was avoided. A route to route extrapolation is proposed from oral route to dermal route: To assess the acute dermal toxicity of 2,4-Diaminophenoxyethanol dihydrochloride, a route to route extrapolation was proposed: Study used for the determination of acute toxicity of 2,4-Diaminophenoxyethanol dihydrochloride: Acute Oral Toxicity study result (X. Manciaux. 2952: Acute Oral Toxicity in Rats. CIT Study No. 17303 TAR, 1998) LD50 oral: Under the experimental conditions, the LD50 of the test item was close to 1000 mg/kg bw since a single dose of 1000 mg/kg induced death in 1/5 male and 3/5 female rats. 1000mg/kg bw in the rat. Toxicokinetic study results in Sprague Dawley rats: Dose levels: Bioavailability, assuming 50% Oral (default value recommended by the SCCS) Dermal dosing: 1.68 ± 1.23%, Extrapolation from oral to dermal: LD 50 oral: 1000 mg/kg bw Oral Bioavailability = 50% Determination of the correction factor oral vs. inhalation route: 50% oral vs. 1.68% dermal = 29.76 LD50 calc dermal: 1000 mg/kg bw x 29.76 = 29760 mg/kg bw