Alcohols, C12-14, ethoxylated, sulfates, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C12-14, ethoxylated, sulfates, sodium salts

EC Number:

500-234-8

EC Name:

Alcohols, C12-14, ethoxylated, sulfates, sodium salts

Cas Number:

68891-38-3

Molecular formula:

not applicable, UVCB

IUPAC Name:

Alcohols, C12-14(even numbered), ethoxylated < 2.5 EO, sulfates, sodium salts

Test animals

Species:

rat

Strain:

other: CFY (Sprague-Dawley origin)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd., Huntingdon, UK
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 99 - 149 g
- Fasting period before study: overnight prior to dosing
- Housing: housed in groups by sex in metal cages with wire mesh floors
- Diet: standard laboratory rodent diet (Labsure LAD1); ad libitum
- Water (e.g. ad libitum): water not further specified; ad libitum
- Acclimation period: at least 6 days


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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000, 3200, 4000, 5000 mg/kg bw

No. of animals per sex per dose:

5
(2 on one of the 4 experimental days (8 apr 1986))

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (main study), 5 days (preliminary study)
- Frequency of observations and weighing: clinical observations were performed after dosing, then at frequent intervals for the remainder of Day1. On subsequent days, the animals were observed once in the morning and again at the end of the experimental day. Body weights were recorded on Day 1 (day of dosing), 8 and 15 and at death.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes, recorded

Statistics:

The acude median lethal oral dose (LD50) to male and female rats was calculated using mortality data from the limit test and main study. The calculation method was Finney Probit Analysis (1971). A chi-square test was carried out.

Results and discussion

Preliminary study:

Groups of 10 rats (5 males and 5 females) were dosed at 2.0, 3.2, 4.0 and 5.0 g/kg test substance. The LD50 was between 2.5 - 4.0 g/kg bw.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 100 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 700 - <= 4 600

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

4 000 mg/kg bw

Based on:

test mat.

95% CL:

>= 3.3 - <= 4.6

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

4 300 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 700 - <= 5 100

Effect levels 4

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 870 mg/kg bw

Based on:

act. ingr.

Mortality:

There were deaths among animals dosed at 4000 and 5000 mg/kg bw one hour after dosing or on Day 2 (see Table 1 under "Any other information on results incl. tables."). Autopsy revealed renal pallor in those dosed at 4.0 g/kg and, in two females dosed at 5.0 g/kg, pallor of the liver, spleen and kidneys and the presence of blood in the thoracic or thoracic and abdominal cavities. Body weight losses were also recorded for rats that died.

Clinical signs:

diarrhoea

lethargy (hypoactivity)

salivation

other: piloerection, hunched posture, abnormal gait (waddling), decreased respiratory rate, pallor of extremities, ptosis

Body weight:

lower than 10% body weight loss

Remarks:

One female rat dosed at 4.0 g/kg showed low body weight gain between Days 8 - 15. All other rats achieved anticipated body weight gains throughout the study.

Gross pathology:

No effects.

Other findings:

Recovery, as judged by external appearance and behaviour, was apparently complete by Day 6.

Any other information on results incl. tables

Table 1: Mortalities

 

Sex	Dose (g/kg bw)	Number of deaths	Time point after dosing
male	2.0	0/5
	3.2	0/5
	4.0	4/5	all 2 days (first observation)
	5.0	4/5	all 2 days (first observation)
female	2.0	0/5
	3.2	0/5
	4.0	2/5	all 2 days (first observation)
	5.0	4/5	2 IDs 1 h, 2 IDs 2 days (first observation)

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Conclusions:

In the present acute oral toxicity study compliant with OECD test guideline 401, administration of the test item lead to mortality at doses 4.0 and 5.0 g/kg in rats. Clinical symptoms occurred from 3.2 g/kg and higher, but resolved at Day 6 after treatment. Based on the results, the LD50 in males and females was set to 2870 mg/kg bw. Due to the experimental set-up, this result can be interpreted as either Acute Toxicity Category 5 (GHS 2017), or unclassified (Regulation (EC) No 1272/2008).