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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Oral LD50  > 5000 mg/kg bw for rat (limit test; test material contained 89% active ingredient and 10% urea)

Dermal LD50 > 5 mL/kg bw for rat (limit test)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Acute oral toxicity:

The key study on oral toxicity (Ciba 801993, 1981) was performed pre-GLP but was conducted using a method similar to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method). Five male and four female young adult rats (Tif: RAIf, SPF) were given a single dose of 5000 mg/kg bw in 20 ml/ kg bw. The vehicle was water containing 2% CMC and 0.1% Tween 80. No animal died. Dyspnea, exophthalmus, ruffled fur, diarrhea and curved body position were observed. The animals recovered within six days and did no show any symptoms until the end of the observation period of 14 days. At autopsy, no deviations from normal morphology were found in surviving animals. The test item contained 89% active ingredient as well as 10% urea.

In a supporting study performed pre-GLP similar to OECD 401 (Ciba 785729, 1978), five male and female young adult albino rats were given a single dose of either 5000, 6000 or 7000 mg/kg bw. One animal per sex died in each dose group except for males at 5000 mg/kg bw. Death occurred between day 3 and 9. Sedation, dyspnea, exophthalmus, ruffled fur, and curved body position were observed. The animals recovered within the observation period. At autopsy, no deviations from normal morphology were found in surviving animals. The test item contained 67% active ingredient as well as NaCl. No comment is made in the study report if the dose refers to the active ingredient or the product.

Additionally in a non GLP guideline study (OECD 423)(CIBA 875185, 1987), three male and three female young adult albino rats were given a single dose of 5000 mg/kg bw. No animal died. Dyspnea, exophthalmus, ruffled fur, and curved body position were observed. The animals recovered within 10 days. At autopsy, no deviations from normal morphology were found. The test item contained 20% active ingredient, 79% water and 1% TEA-HCl buffer. No comment is made in the study report if the dose refers to the active ingredient or the product.

Furthermore, in a non-GLP study (Bayer AG T9034598 (1990)) performed according to EU Method B.1 (Acute Toxicity (Oral)), five female Wistar rats were given a single dose of 2000 mg/kg bw of the test material (which contained 36% active ingredient). No animal died . No effects were observed on bodyweight, clinical signs and gross-pathology.

In a fourth supporting study (BASF AG 81/115 (1981)), perfomed pre-GLP according to OECD 401, treatment of five male and five female Sprague Dawley rats with a single dose of 5000 mg/kg bw test material (containing 14.5% active ingredient, 83% water, 1.5% NPG and 1% salts) did not result in mortalities. No adverse effect on bodyweight or on gross pathology were found. Red skin and urine in male and female animals on day 1 and 2 were noted though.

In addition read across data are available for Analogue substance 1. The Clariant (2007) study was performed to assess the acute oral toxicity of the test material following a single oral administration in Sprague-Dawley CD strain rat (SPL Standard Test Method 518.04). The method followed the OECD Guidelines for the Testing of Chemicals No 420 "Acute Oral Toxicity - Fixed Dose Method" (adopted l7 December 2001). The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System Category - Unclassified)

An older read across study with Analogue substance 1 (Clariant 2002) assessed the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley Crl:CD@ (SD) IGS BR rat (SPL Standard Test Method 512.08). The method followed the OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 22 March 1996), EU Commission Directive 96/54/EEC Method B1 tris Acute Oral Toxicity (Oral - Acute Toxic Class Method). The acute oral median lethal dose (LD50) of the test material was estimated as being greater than 2500 mg/kg bodyweight.

Acute dermal toxicity:

In a non-GLP study according to OECD Guideline 402 (Acute Dermal Toxicity) five male and five female Wistar rats were dermally exposed to 5.020 mL / kg test substance. The experimental animals were shaved at a back area of 6x6 cm (with an electric razor) on wich the pure test subtance was applied. Exposure lasted for 24 hours and the total observation time was 14 days. At autopsy, animals killed after 14 days of the observation period did not present patho-morphological changes, no clinical signs were observed but slight decrease in bodyweigth was noted.

Justification for classification or non-classification

Based on the observed oral LD50 of >5000 mg/kg bw and the dermal LD50 of > 5 mL/kg bw in the acute toxicity studies in rats, the test substance does not need to be classified according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.