Carboxylic acids, C5-9

Endpoint summary

Description of key information

A recent GLP study carried out according to OECD 423 is available.

According to this study the substance has a LD50 > 2000 mg/kg bw and being corrosive to the skin according to the studies carried out following the OECD guidelines 431 and 435, the other two routes are waived.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017 - 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Remarks:

nulliparous and non-pregnant

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS s.r.l., San Pietro al Natisone (UD), Italy
- Age at study initiation: 6-7 weeks old
- Weight at study initiation: 170.3-173.6 grams
- Fasting period before study: food was removed from the cage overnight prior to dosing
- Housing:Polisulphone solid bottomed cage measuring 59,5x38x20 cm with nesting material provided into suitable bedding bags
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +- 2°C
- Humidity (%): 55% +- 15%
- Air changes (per hr): 15 to 20/ hour
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10mL/kg

Doses:

2000mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 2x/day
- Necropsy of survivors performed: yes

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occured

Clinical signs:

other: no clinical signs were observed in the 2 groups of animals initially dosed at 2000mg/kg

Study: A3029A

Study Title: ACUTE ORAL TOXICITY STUDY IN RATS (ACUTE TOXIC CLASS METHOD)                

Animal Group	Day of phase	Day 1	Day 5	Day 10	Day 15
1	Number examined	3	3	3	3
	Number with no observation(s)	3	3	3	3
2	Number examined	3	3	3	3
	Number with no observation(s)	3	3	3	3

Interpretation of results:

GHS criteria not met

Conclusions:

Acute toxicity for Carboxylic Acids, C5-9 is expected to be greater than 2000 mg/kg body weight.

Executive summary:

The acute toxicity of Carboxylic acids, C5 -9 was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period. A first group of 3 female animals was initially dosed at 2000 mg/kg (Step 1). No mortality occurred and no clinical signs were observed. A second group of 3 female animals was then dosed at the same dose level (Step 2). No death occurred and no clinical signs were noted. Body weight changes recorded during the study were within the expected range for this strain and age of animals. No abnormalities were observed at necropsy examination performed at the end of the observation period on animals of both groups. These results indicate that the test item Carboxylic Acids, C5 -9 did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:

- Classification: not required

- Signal word: not required

- Labeling: not required

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Justification for type of information:

According to the avilable studies according to OECD 431 and OECD 435, this substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of acute toxicity – oral endpoint
There is only one study available but this study is a well documented, and performed recent GLP study according to international guidelines.

The substance is corrosive to the skin, then the other routes (inhalation and dermal) are waived.

Justification for classification or non-classification

Based on the acute toxicity results, showing LD50 values > 2000 mg/kg bw for oral administration,the substance should not be classified as acute toxic according to the criteria described in EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP).