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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 100 mg/kg bw
Based on:
test mat.
95% CL:
>= 3 700 - <= 4 600
Sex:
male
Dose descriptor:
LD50
Effect level:
4 000 mg/kg bw
Based on:
test mat.
95% CL:
>= 3.3 - <= 4.6
Sex:
female
Dose descriptor:
LD50
Effect level:
4 300 mg/kg bw
Based on:
test mat.
95% CL:
>= 3 700 - <= 5 100
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 deathsTime point after dosing
male2.00/5 
3.20/5 
4.04/5all 2 days (first observation)
5.04/5all 2 days (first observation)
female2.00/5 
3.20/5 
4.02/5all 2 days (first observation)
5.04/52 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).