Fatty acids, C16-18, 2-butyloctyl esters

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

vapour pressure

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test procedure according to guideline (OECD) test method without GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 104 (Vapour Pressure Curve)

Deviations:

no

GLP compliance:

no

Type of method:

dynamic method

Temp.:

20 °C

Vapour pressure:

ca. 0 Pa

Remarks on result:

other: calculated

Temp.:

50 °C

Vapour pressure:

0 Pa

Remarks on result:

other: calculated

Experimental vapour pressure data:

T [K]	P [kPa]
479.02	0.039
487.57	0.066
492.57	0.088
503.18	0.16
509.54	0.22
515.72	0.30
523.77	0.43
530.18	0.58
539.95	0.88
549.46	1.31
558.61	1.88
569.19	2.85
578.41	4.10
588.61	5.98
593.34	7.45

Conclusions:

Calculated vapour pressure at 20 °C 5.7 E-10 kPa and at 50 °C 4.8 E-08 kPa.

Executive summary:

The vapour pressure was measured with OECD 104 guideline method in a temperature range from 479.02 K to 593.34 K. To the experimental data Antoine parameters were fitted. Calculated values at 20 and 50 °C are given.

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Due to the structural similarities and consistent trend in toxicokinetic and (eco)toxicological behaviour, the selected source substances are considered suitable and systemic human health effects and ecotoxicological effects can be directly read-across in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5.

Reason / purpose for cross-reference:

read-across source

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

not examined

Details on results:

CLINICAL SIGNS AND MORTALITY
All doses applied were tolerated without lethality. No symptoms were noted as compound-related effects.

BODY WEIGHT AND WEIGHT GAIN
The total body weight gain was comparable to control in all male and female test groups.

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
The mean food consumption of all groups was comparable to the control.

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study)
The mean water intake of the male groups 2 and 4 showed a slight increase which was not considered to be compound-related.

OPHTHALMOSCOPIC EXAMINATION
The examination of the eyes by slit lamp microscope showed no compound-related effects.

HAEMATOLOGY
The haematological examinations showed no compound-related effects.

CLINICAL CHEMISTRY
The clinical chemistry showed no compound-related effects.

ORGAN WEIGHTS
The absolute and relative organ weights showed no compound-related effects.

GROSS PATHOLOGY
The macroscopical examination of the organs showed no compound-related effects. Some observations like hydrometra, hydronephrosis,
discolouration of the thymus and one suspicion of hydrocephalus internus were considered to be spontaneous.

HISTOPATHOLOGY: NON-NEOPLASTIC
The histological examination of the organs of all groups displayed no compound-related effects.
The histological examination of the organs of the recovery group was not performed, because in the main groups no target organ was evaluated.

Key result

Dose descriptor:

NOEL

Effect level:

1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: see 'Remark'

Key result

Critical effects observed:

not specified

Conclusions:

According to the described study, a daily administration of 2-Ethylhexylstearate up to 1000 mg/kg bodyweight/day for 28 days caused no cumulative-systemic toxicity to rats. The NOAEL was found to be 1000 mg/kg bw/day.

Executive summary:

2-Ethylhexylstearate was tested for systemic toxicity at repeated doses of 0 (group 1), 100 (group 2), 500 (group 3) and 1000 (group 4) mg/kg body weight/day. The compound was administered daily by gavage over a period of 28 days. 10 male and 10 female rats were used for each dose. In addition to the groups 1 and 4, 5 male and 5 female animals were used to determine the reversibility of possible compound-related findings (recovery group).

 

All doses applied were tolerated without lethality. No symptoms were noted as compound-related effects. The mean food consumption of all groups was comparable to the control. The mean water intake of the male groups 2 and 4 showed a slight increase which was not considered to be compound-related. The total body weight gain was comparable to control in all male and female test groups. The haematological examinations showed no compound-related effects. The clinical chemistry showed no compound-related effects. The examination of the eyes by slit lamp microscope showed no compound-related effects. The absolute and relative organ weights showed no compound-related effects. The macroscopical examination of the organs displayed no compound-related effects. Some observations like hydrometra, hydronephrosis, discolouration of the thymus and one suspicion of hydrocephalus internus (animal No. 67) were considered to be spontaneous. The histological examination of the organs of all groups displayed no compound-related effects.The histological examination of the organs of the recovery group was not performed, because in the main groups no target organ was evaluated.

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified