Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Fatty acids, montan wax, mixed esters with fatty acids C16-18 and ethylene glycol and Fatty acids, montan-wax, stearyl esters and Montan wax

Endpoint summary

Description of key information

Based on the available reliable studies on different Montan waxes, the LD50 values for oral and dermal exposure of all tested category members are consistently above at least 2000 mg/kg bw. No information is available for the inhalation route, however, inhalation exposure is considered unlikely.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 18 Jun 2017 to 3 Aug 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

17 December 2001

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Version / remarks:

30 May 2008

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 12 weeks
- Weight at study initiation: 236 - 253 g
- Fasting period before study: overnight
- Housing: individually (pre-tests), group of 4 (main study)
- Diet (ad libitum): ssniff® SM R/M "Autoclavable complete diet for rats and mice - breeding and maintenance" by ssniff Spezialdiäten GmbH, Soest, Germany
- Water (ad libitum): tap water from the municipal supply
- Acclimation period: at least 35 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 – 24.3
- Humidity (%): 31 – 70 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 or 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: due to lack of any preliminary toxicological information, 300 mg/kg bw was selected to be the starting dose

Doses:

300, 2000 mg/kg bw

No. of animals per sex per dose:

1 in pre-tests (300, 2000 mg/kg bw), 4 in main study (2000 mg/kg bw)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter, weighing on the day before treatment (Day -1), on the day of the
treatment (Day 0) and on Day 7 and Day 14 (before necropsy).
- Necropsy of survivors performed: yes

Statistics:

not performed

Preliminary study:

No mortality was observed in 1 female rat each exposed to 300 or 2000 mg/kg bw

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no evidence of any macroscopic changes in the surviving rats

Mortality:

not observed

Clinical signs:

other: not observed

Gross pathology:

no effects

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this acute toxicity test according to OECD guideline 420, the LD50 in female rats was > 2000 mg/kg bw

Executive summary:

The acute oral toxicity study with WARADUR LG was performed according to the acute toxic class method (OECD 420 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.bis) in Crl:WI Wistar female rats.

Initially, in the sighting study, one female was treated at the dose level of 300 mg/kg bw. As no mortality was observed, one female was treated at the dose level of 2000 mg/kg bw. As no mortality was observed, the main study was conducted with four animals treated at the same dose level. No mortality was observed in the main study; therefore, no further testing was required.

A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was administered formulated in PEG 400 at a concentration of 30, or 200 mg/mL at a dosing volume of 10 mL/kg bw.

Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0 and 7 and Day 14 (before necropsy). All animals were subjected to a necropsy and a macroscopic examination.

WARADUR LG did not cause mortality in the study. All treated animals were symptom-free during the observation period. Body weight gains of WARADUR LG treated animals during the study showed no indication of a treatment-related effect. There was no evidence of any macroscopic changes in the surviving rats at the dose levels of 300 and 2000 mg/kg bw.

Under the conditions of this study, the acute oral LD50 value of the test item WARADUR LG was found to be above 2000 mg/kg bw in female Crl:WI Wistar rats.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Justification for type of information:

For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.

Reason / purpose for cross-reference:

assessment report

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Montan wax, type S

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Montan wax, type E

Interpretation of results:

GHS criteria not met

Conclusions:

In reliable studies members of the category of Montan waxes proved to be not not toxic to rats after oral exposure (LD50 at least > 2000 mg/kg).

Executive summary:

The studies used as source investigated the acute oral toxicity of members from the category of Montan waxes.

The study results of the source compounds were considered applicable to the target compound and were used for classification and labelling acc. to REGULATION (EC) No 1272/2008. Justification and

applicability of the read-across approach (category approach) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Reliable guideline studies with Klimisch score 1 or studies equivalent to gudelines with Klimisch score 2 are available for several members of the category.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Justification for type of information:

For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.

Reason / purpose for cross-reference:

assessment report

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Montan wax, type E

Interpretation of results:

GHS criteria not met

Conclusions:

In reliable studies members of the category of Montan waxes proved to be not not toxic to rats after dermal exposure (LD50 > 2000 mg/kg).

Executive summary:

The study used as source investigated the acute dermal toxicity of a member from the category of Montan waxes.

The study results of the source compounds were considered applicable to the target compound and were used for classification and labelling acc. to REGULATION (EC) No 1272/2008. Justification and

applicability of the read-across approach (category approach) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

A reliable guideline study with Klimisch score 1 is available for a member of the category.

Additional information

Discussion

Oral exposure

Guideline studies on acute toxicity after oral application in rats (RL1) are available for Montan waxes, types WE 4, E, WE 40, and LG. The LD50 values in all these studies were above 2000 mg/kg bw.

Montan waxes, type S and type NaV 101 were tested in studies performed similar to guideline OECD 401 (RL2) and both revealed LD50 values > 15000 mg/kg bw.

These results are supported by further studies: poorly documented studies (RL3) reported LD50 values for Montan waxes, type KPS of > 15000 mg/kg bw and > 10000 mg/kg bw in rats and mice, respectively.

 

Inhalation exposure

This information is not available. Inaccordance with column 2 of section 8.5 of REACH Annex VIII, an acute inhalation toxicity study is not necessary because exposure of humans via inhalation is considered unlikely taking into account the vapour pressure of the substance and the physical form of the substances.

 

Dermal exposure

The acute dermal toxicity was tested with Montan waxes, type E in a guideline study (RL1), which resulted in no mortality up to doses of 2000 mg/kg bw. Thus the LD50 is > 2000 mg/kg bw.

Justification for classification or non-classification

Oral and dermal LD50 values for the members of the Montan waxes category are consistently > 2000 mg/kg bw, the limit for classification. According to the category approach the results of the key studies are read across to all members of the Montan waxes category (see Chapter 1 of the CSR for justification for read-across). Therefore, the Montan waxes category members have not to be classified for acute toxicity according to Regulation (EC) No 1272/2008.