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REACH

N,N'-(ethoxymethylsilylene)bis[N-methylbenzamide]

EC number: 240-354-5 | CAS number: 16230-35-6

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Administrative data

Description of key information

Acute toxicity: oral.

Key study: OECD 423 and EU method B.1 tris. GLP study. The LD50 was found to be betwwen 300 and 2000 mg/kg bw, the LD50 cut-off of the test item may be considered as 500 mg/kg body weight by oral route in the rat.

Acute toxicity: inhalation.

Data waiving (study not necessary / other information available): The study does not need to be conducted because there is availabe data on oral and dermal acute toxicity of the substance.

Acute toxicity: dermal.

Key study: OECD 402 and EU B.3. GLP study. The dermal LD50 of the test item in rats is greater than 2000 mg/kg bw. Erythema was noted at 48h, but it was fully reversible at Day 3.

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:: November 15, 2016 - December 6, 2016
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 (incl. QA statement)
Test type:: acute toxic class method
Limit test:: yes
Specific details on test material used for the study:: STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature.
Species:: rat
Strain:: Sprague-Dawley
Sex:: female
Details on test animals or test system and environmental conditions:: TEST ANIMALS
- Source: Elevage JANVIER LABS (F-53941 Le genest St. Isle)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks old
- Weight at study initiation: Step 1: 203 ± 7.0; Step 2 and 3: 214.8 ± 6.3
- Fasting period before study: overnight
- Housing: Rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet: foodstuff (ENVIGO - 2016) ad libitum
- Water: tap-water from public distribution system ad libitum. Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas-eurofins (France)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19ºC - 25ºC
- Humidity (%): 30% - 70%
- Air changes (per hr): Ten changes per hour
- Photoperiod (hrs dark / hrs light): Twelve hours light (07.00 to 19.00) / twelve hours darkness.

IN-LIFE DATES: From: November 15, 2016 To: December 6, 2016
Route of administration:: oral: gavage
Vehicle:: olive oil
Details on oral exposure:: VEHICLE
- Concentration in vehicle: In first step, test item was administered corresponding to 2g/kg, according to the calculated density. In second and third step, 0.27 mL of the test item (corresponding to 300 mg) were added to 1.54 mL of olive oil.
- Amount of vehicle (if gavage): 1.81 mL/kg.
- Justification for choice of vehicle: it produced the most suitable formulation at the requested concentration.

MAXIMUM DOSE VOLUME APPLIED: 1.81 mL/kg.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Whitout preliminary information. The selected starting dose is 2000 mg/kg body weight.
Doses:: 2000 mg/kg, 300 mg/kg
No. of animals per sex per dose:: 3 (Step 1)
6 (Step 2)
Control animals:: yes
Remarks:: Study No. TAO423-2016-005 (see "Other information on results").
Details on study design:: - Duration of observation period following administration: 14 days .
- Frequency of observations and weighing: Systemic observations at 30 min, 1h, 3h, 4h, 24h, 48h after administration and daily during 14 days. Weighing: on Day 0 (just before administering the test item) then on Day 2, Day 7, and Day 14.
- Necropsy of survivors performed: yes.
At the end of the study, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. No organ was removed and preserved in view to microscopic examinations.
- Other examinations performed:
Body weight and body weight gain: the animals were weighted on D0 (just before administering the test item) then on D2, D7, and D14.
Clinical signs: Spontaneous activity, Preyer's reflex (noise), Respiratory rate, Convulsions, Tremors, Body temperature, Muscle tone, Palpebral opening, Pupil appearance, Salivation, Lachrymation, Righting reflex, Back hair appearance, Mortality.
Gross pathology: On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Parameters examined: Oesophagus, Stomach, Duodenum, Jejunum, Ileon, Caecum, Colon, Rectum, Spleen, Liver, Thymus, Trachea, Lungs, Heart, Kidneys, Urinary Bladder, Ovaries, Uterus, Treatment Area, Adrenals and Pancreas.
: Key result
Sex:: female
Dose descriptor:: LD50
Effect level:: > 300 - < 2 000 mg/kg bw
Based on:: test mat.
Sex:: female
Dose descriptor:: LD50 cut-off
Effect level:: ca. 500 mg/kg bw
Based on:: test mat.
Mortality:: At the dose of 2000 mg/kg bw, all three animals died (3/3), two at 24 hours post dose and one other at 48 hours post dose.
No mortality occurred during the study at the dose of 300 mg/kg.
Clinical signs:: At 2000 mg/kg bw: the mortalities were preceded by an absence or decrease in spontaneous activity (3/3), muscles tones (3/3), righting reflex (3/3), Preyer's reflex (3/3), associated with bradypnea (3/3), dyspnea (1/3), hypothermia (3/3), eyes partly (2/3) or totally (2/3) closed, mydriasis (3/3), an increase of salivation (1/3) and piloerection (1/3). Rigor mortis were noted before the necropsy (3/3).
At 300 mg/kg bw: no clinical signs related to the administration of the test item were observed during the study.
Body weight:: At 300 mg/kg bw: the body weight evolution of the animals remained normal throughout the study.
Gross pathology:: At 2000 mg/kg bw: the macroscopic examination of the animals revealed a thinning of a forestomach and corpus (1/3), a swelling of the stomach (2/3), red coloration of a forestomach and corpus (2/3). Furthermore, cellular lysis of main organs in the abdomen was noted (2/3).
At 300 mg/kg bw: the macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
Interpretation of results:: Category 4 based on GHS criteria
Conclusions:: The LD50 of the test item is higher than 300 mg/kg bw and lower than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered as 500 mg/kg body weight by oral route in the rat.
Executive summary:: The acute oral toxicity of the test item has been tested in accordance with OECD 423 and EU method B.1 tris, following GLP. The test item was administered, as supplied, to a group of 3 female Sprague-Dawley rats at the dose of 2000 mg/kg and 6 female Sprague-dawley rats at the dose of 300 mg/kg body weitght by oral gavage. At the highest dose, all three animals died (3/3), two at 24 hours post dose and one other at 48 hours post dose. The mortalities were preceded by an absence or decrease in spontaneous activity (3/3), muscles tones (3/3), righting reflex (3/3), Preyer's reflex (3/3), associated with bradypnea (3/3), dyspnea (1/3), hypothermia (3/3), eyes partly (2/3) or totally (2/3) closed, mydriasis (3/3), an increase of salivation (1/3) and piloerection (1/3). Rigor mortis were noted before the necropsy (3/3). The macroscopic examination of the animals revealed a thinning of a forestomach and corpus (1/3), a swelling of the stomach (2/3), red coloration of a forestomach and corpus (2/3). Furthermore, cellular lysis of main organs in the abdomen was noted (2/3). At the dose of 300 mg/kg, no mortality occurred during the study and the body weight evolution of the animals remained normal during the study. Furthermore, no clinical signs related to the administration of the test item were observed during the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes. The LD50 of the test item is higher than 300 mg/kg bw and lower than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered as 500 mg/kg body weight by oral route in the rat. Based on the available information, the test item has to be classified in category 4 according to CLP Regulation (EC) no. 1272/2008.

Endpoint conclusion

Endpoint conclusion:: adverse effect observed
Dose descriptor:: LD50
Value:: 500 mg/kg bw
Quality of whole database:: Klimish score 1.

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:: other:
Justification for type of information:: JUSTIFICATION FOR DATA WAIVING
Study scientifically not necessary / other infr¡ormation available: the study does not need to be conducted because there is availabe data on oral and dermal acute toxicity of the substance.

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:: experimental study
Adequacy of study:: key study
Study period:: February 14, 2017 - February 28, 2017
Reliability:: 1 (reliable without restriction)
Rationale for reliability incl. deficiencies:: guideline study
Qualifier:: according to guideline
Guideline:: OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:: no
Qualifier:: according to guideline
Guideline:: EU Method B.3 (Acute Toxicity (Dermal))
Deviations:: no
GLP compliance:: yes (incl. QA statement)
Test type:: fixed dose procedure
Limit test:: yes
Specific details on test material used for the study:: STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature.
Species:: rat
Strain:: Sprague-Dawley
Sex:: male/female
Details on test animals or test system and environmental conditions:: TEST ANIMALS
- Source: Elevage JANVIER LABS (53940 Le Genest St Isle - France).
- Females nulliparous and non-pregnant: yes.
- Age at study initiation: male animals of the treated group were 7 weeks old and the female were 8 weeks old.
- Weight at study initiation: males= 226.4 ± 4.9, females= 203.2 ± 5.4.
- Fasting period before study: no.
- Housing: during the treatment, the animals were in individual cages. On D1, the animals were put into their cage by 5. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains dust free weed shavings which were changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet (e.g. ad libitum): foodstuff (ENVIGO 2016) ad libitum.
- Water (e.g. ad libitum): tap-water from public distribution system ad libitum. Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas - Eurofins (France).
- Acclimation period: at least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19ºC - 25ºC.
- Humidity (%): 30% - 70% (a relative humidity lower than 30% was registered on 18, 19, 25, 26 and 28 February 2017, the minimum valued measured was 18%).
- Air changes (per hr): at least ten changes cycles per hour.
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07:00 to 19:00) and telve hours darkness.

IN-LIFE DATES: From: To: 14 February 2017 - 28 February 2017.
Type of coverage:: other: non-occlusive
Vehicle:: water
Details on dermal exposure:: TEST SITE
- Area of exposure: dorsal area of the trunk of the animal.
- % coverage: 10% of the body surfade area.
- Type of wrap if used: non-occlusive porous gauze dressing (50x50 mm2 non woven swab, 4-layer patch, MEDISTOCK) secured in position with a strip of surgical adhesive tape (50 mm wides hypoallergenic micropore TM adhesive tape from 3M).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after removing the gauze dressings, the treated area was rinsed with destilled water and liquid paraffin.
- Time after start of exposure: 24 h.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.81 mL/kg bw.
- Concentration (if solution): 0.2 g/ml.
- Constant volume or concentration used: yes.
- For solids, paste formed: no.

VEHICLE
- Amount(s) applied (volume or weight with unit): 10 mL/Kg bw.
Duration of exposure:: 24 h
Doses:: 2000 mg/kg bw
No. of animals per sex per dose:: 5 males and 5 females per dose.
Control animals:: yes
Remarks:: Study No. TAD-2016-004 (see "Other information on results").
Details on study design:: - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: daily observations, the animals were weighed on day 0 (just before administering the test item) then on day 2, day 7, and day 14.
- Necropsy of survivors performed: yes.
At the end of the study, the animals were euthanized with sodium pentobarbital (Dolethal®). Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. No organ was removed and preserved in view to microscopic examinations.
- Other examinations performed:
Body weight and body weight gain: the animals were weighted on D0 (just before administering the test item) then on D2, D7, and D14.
Clinical signs: Spontaneous activity, Preyer's reflex (noise), Respiratory rate, Convulsions, Tremors, Body temperature, Muscle tone, Palpebral opening, Pupil appearance, Salivation, Lachrymation, Righting reflex, Treatment site, Mortality.
Gross pathology: On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Parameters examined: Oesophagus, Stomach, Duodenum, Jejunum, Ileon, Caecum, Colon, Rectum, Spleen, Liver, Thymus, Trachea, Lungs, Heart, Kidneys, Urinary Bladder, Ovaries, Uterus, Treatment Area, Adrenals and Pancreas.
: Key result
Sex:: male/female
Dose descriptor:: LD50
Effect level:: > 2 000 mg/kg bw
Based on:: test mat.
Remarks on result:: other: erythema was noted in all animals at 48h, but it was fully reversible at day 3
Mortality:: No mortality occurred during the study.
Clinical signs:: No systemic clinical signs related to the administration of the test item were observed.
Erythema was noted in treated females (5/5) at 48 hours post dose. This reaction was totally reversible at day 3.
Despite this rinse of the treated area (with distilled water and then with liquid paraffin), residual test item was noted on the treated area at 24 and 48 hours post-dose in treated females and at 24 hours post-dose in treated females and at 24 hours post-dose in treated males.
See more details in Tables 1 to 4.
Body weight:: The body weitght evolution of the animals remained normal throughout the study.
See complete details in Table 5.
Gross pathology:: The macroscopic examination of the animals at the end of the study did not reveal treatment-realted changes.
See more details in Table 6 and 7.
Interpretation of results:: GHS criteria not met
Conclusions:: The dermal LD50 of the test item in rats is greater than 2000 mg/kg bw.
Executive summary:: A limit test was performed to determine the acute dermal toxicity of the test item in rats according to OECD 402 and EU method B.3, following GLP. The test item was applied onto the intact skin of 10 Sprague Dawley rats (5 males, 5 females) at a dose of 2000 mg/kg bw. All animals were observed once daily for 14 days, survival and body weight were monitored. All animals werte examined macroscopically at the end of the study. There were no mortality ans systemic clinical signs related to the administration of the test irem during the study. Erythema was noted in treated females (5/5) at 48 hours post dose and the reaction was reversible at day 3. Residual test item was also noted on the treated area at 24 and 48 hours post-dose in treated females and at 24 hours post-dose in treated males. Normal changes in body weights and none macroscopic findings were found. In conclusion, the test item was found to be non toxic by dermal route, with an LD50 higher than 2000 mg/kg bw in rats.

Endpoint conclusion

Endpoint conclusion:: no adverse effect observed
Dose descriptor:: LD50
Value:: 2 000 mg/kg bw
Quality of whole database:: Klimish score 1.

Additional information

Acute toxicity: oral.

Key study: The acute oral toxicity of the test item has been tested in accordance with OECD 423 and EU method B.1 tris, following GLP. The test item was administered, as supplied, to a group of 3 female Sprague-Dawley rats at the dose of 2000 mg/kg and 6 female Sprague-dawley rats at the dose of 300 mg/kg body weitght by oral gavage. At the highest dose, all three animals died (3/3), two at 24 hours post dose and one other at 48 hours post dose. The mortalities were preceded by an absence or decrease in spontaneous activity (3/3), muscles tones (3/3), righting reflex (3/3), Preyer's reflex (3/3), associated with bradypnea (3/3), dyspnea (1/3), hypothermia (3/3), eyes partly (2/3) or totally (2/3) closed, mydriasis (3/3), an increase of salivation (1/3) and piloerection (1/3). Rigor mortis were noted before the necropsy (3/3). The macroscopic examination of the animals revealed a thinning of a forestomach and corpus (1/3), a swelling of the stomach (2/3), red coloration of a forestomach and corpus (2/3). Furthermore, cellular lysis of main organs in the abdomen was noted (2/3). At the dose of 300 mg/kg, no mortality occurred during the study and the body weight evolution of the animals remained normal during the study. Furthermore, no clinical signs related to the administration of the test item were observed during the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes. The LD50 of the test item is higher than 300 mg/kg bw and lower than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered as 500 mg/kg body weight by oral route in the rat. Based on the available information, the test item has to be classified in category 4 according to CLP Regulation (EC) no. 1272/2008.

Acute toxicity : dermal.

Key study: A limit test was performed to determine the acute dermal toxicity of the test item in rats according to OECD 402 and EU method B.3, following GLP. The test item was applied onto the intact skin of 10 Sprague Dawley rats (5 males, 5 females) at a dose of 2000 mg/kg bw. All animals were observed once daily for 14 days, survival and body weight were monitored. There were no mortality ans systemic clinical signs related to the administration of the test irem during the study. Erythema was noted in treated females (5/5) at 48 hours post dose and the reaction was reversible at day 3. Residual test item was also noted on the treated area at 24 and 48 hours post-dose in treated females and at 24 hours post-dose in treated males. Normal changes in body weights and none macroscopic findings were found. In conclusion, the test item was found to be non toxic by dermal route, with an LD50 higher than 2000 mg/kg bw in rats.

Justification for classification or non-classification

Based on the available data (300 mg/kg-bw<LD50< 2000 mg/kg-bw), the substance is classified for Acute Oral Toxicity Category 4, H302: Harmful if swallowed, in accordance with CLP Regulation (EC) No. 1272/2008.

Based on the available data (LD50> 2000 mg/kg-bw), the substance is not classified for Acute Dermal Toxicity in accordance with CLP Regulation (EC) No. 1272/2008.

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

OBSERVATIONS:	FEMALES
T0 + 30 minutes	Rf 0709	Rf 0710	Rf 0711
Spontaneous activity	D	0	D
Preyer’s réflex (noise)	D	0	D
Repiratory rate	N	N	N
convulsions	N	N	N
tremors	N	N	N
Body temperature	N	N	N
Muscle tone	N	0	D
Palpebral opening	N	N	N
Pupil appearance	N	Md	Md
Salivation	N	N	N
Lachrymation	N	N	N
Ringhting reflex	N	0	D
Back hair appearance	N	N	N
MORTALITY	0	0	0
Remarks	None

OBSERVATIONS:	FEMALES
T0 + 1 hour	Rf 0709	Rf 0710	Rf 0711
Spontaneous activity	0	0	0
Preyer’s réflex (noise)	0	0	0
Repiratory rate	B	B	B
convulsions	N	N	N
tremors	N	N	N
Body temperature	N	D	N
Muscle tone	D	0	D
Palpebral opening	N	Cc	Pc
Pupil appearance	Md	Md	Md
Salivation	N	N	N
Lachrymation	N	N	N
Ringhting reflex	D	0	D
Back hair appearance	N	N	N
MORTALITY	0	0	0
Remarks	None

OBSERVATIONS:	FEMALES
T0 + 3 hours	Rf 0709	Rf 0710	Rf 0711
Spontaneous activity	0	0	0
Preyer’s réflex (noise)	0	0	0
Repiratory rate	B	B	B
convulsions	N	N	N
tremors	N	N	N
Body temperature	D	D	D
Muscle tone	0	0	0
Palpebral opening	Pc	Cc	Cc
Pupil appearance	Md	Md	Md
Salivation	N	N	N
Lachrymation	N	N	N
Ringhting reflex	0	0	0
Back hair appearance	N	N	N
MORTALITY	0	0	0
Remarks	None

OBSERVATIONS:	FEMALES
T0 + 4 hours	Rf 0709	Rf 0710	Rf 0711
Spontaneous activity	0	0	0
Preyer’s réflex (noise)	0	0	0
Repiratory rate	B	B	B
convulsions	N	N	N
tremors	N	N	N
Body temperature	D	D	D
Muscle tone	0	0	0
Palpebral opening	Pc	Cc	Cc
Pupil appearance	Md	Md	Md
Salivation	N	N	N
Lachrymation	N	N	N
Ringhting reflex	0	0	0
Back hair appearance	N	N	N
MORTALITY	0	0	0
Remarks	None

OBSERVATIONS:	FEMALES
D1	Rf 0709	Rf 0710	Rf 0711
Spontaneous activity	0
Preyer’s réflex (noise)	0
Repiratory rate	B
convulsions	N
tremors	N
Body temperature	D
Muscle tone	0
Palpebral opening	Pc
Pupil appearance	N
Salivation	A
Lachrymation	A
Ringhting reflex	0
Back hair appearance	Pi
MORTALITY	0	1	1
Remarks	Rf0710 & Rf0711: found dead at T0 + 22 hours and 39 minutes

FEMALES	D0	D2	D2-D0	D7	D7-D0	D14	D14-D0
Rf 0709	208	†
Rf 0710	206	†
Rf 0711	195	†
MEAN	203.0
Standard deviation	7.0

Found dead: X	Euthanasia:	At term:
GENERAL APPEARANCE BEFORE AUTOPSY: Rigor mortis, found dead at T0 + 22 hours and 39 minutes
	Observed Organs	Observations
* OESOPHAGUS	X	N.t.R.
* STOMACH	X	Forestomach 6 corpus red colored, swollen stomach
* DUODENUM	-	Cell lysis
* JEJUNUM	-	Cell lysis
* ILEON	-	Cell lysis
* CAECUM	-	Cell lysis
* COLON	-	Cell lysis
* RECTUM	-	Cell lysis
* SPLEEN	-	Cell lysis
* LIVER	X	N.t.R.
* THYMUS	X	N.t.R.
* TRACHEA	X	N.t.R.
* LUNGS	X	N.t.R.
* HEART	X	N.t.R.
* KIDNEYS	X	N.t.R.
* URINARY BLADDER	X	N.t.R.
* OVARIES	X	N.t.R.
* UTERUS	X	N.t.R.
* TREATMENT AREA	-	-
* ADRENALS	X	N.t.R.
* PANCREAS	X	N.t.R.
PARTICULARS. None

OBSERVATIONS:	MALES					FEMALES
T0 + 1 hours T0 + 3 hours T0 + 5 hours	Rm 1106	Rm 1107	Rm 1108	Rm 1109	Rm 1110	Rf 1111	Rf 1112	Rf 1113	Rf 1114	Rf 1115
Spontaneous activity	N	N	N	N	N	N	N	N	N	N
Preyer’s réflex (noise)	N	N	N	N	N	N	N	N	N	N
Repiratory rate	N	N	N	N	N	N	N	N	N	N
Convulsions	N	N	N	N	N	N	N	N	N	N
Tremors	N	N	N	N	N	N	N	N	N	N
Body temperature	N	N	N	N	N	N	N	N	N	N
Muscle tone	N	N	N	N	N	N	N	N	N	N
Palpebral opening	N	N	N	N	N	N	N	N	N	N
Pupil appearance	N	N	N	N	N	N	N	N	N	N
Salivation	N	N	N	N	N	N	N	N	N	N
Lachrymation	N	N	N	N	N	N	N	N	N	N
Ringhting reflex	N	N	N	N	N	N	N	N	N	N
MORTALITY	0	0	0	0	0	0	0	0	0	0
Remarks	None					None

MALES	D0	D2			D2-D0	D7	D7-D0		D14	D14-D0
Rm 1106	230	249			19	287	57		327	97
Rm 1107	224	250			26	299	75		353	129
Rm 1108	219	251			32	296	77		354	135
Rm 1109	231	278			47	317	86		372	141
Rm 1110	228	271			43	322	94		354	126
MEAN	226.4	259.8			33.4	304.2	77.8		352.0	125.6
Standard deviation	4.9		13.7	11.6		14.8	13.9	16.1			17.0
FEMALES	D0		D2	D2-D0		D7	D7-D0	D14			D14-D0
Rf 1111	204		202	-2		226	22	252			48
Rf1112	206		221	15		240	34	256			50
Rf 1113	210		201	-9		225	15	240			30
Rf 1114	200		221	21		240	40	256			56
Rf 1115	196		203	7		224	28	243			47
MEAN	203.2		209.6	6.4		231.0	27.8	249.4			46.2
Standard deviation	5.4		10.4	12.2		8.2	9.8	7.5			9.7

Found dead:	Euthanasia: X	At term: X
GENERAL APPEARANCE BEFORE AUTOPSY: Normal
	Observed Organs	Observations
* OESOPHAGUS	X	N.t.R.
* STOMACH	X	N.t.R.
* DUODENUM	X	N.t.R.
* JEJUNUM	X	N.t.R.
* ILEON	X	N.t.R.
* CAECUM	X	N.t.R.
* COLON	X	N.t.R.
* RECTUM	X	N.t.R.
* SPLEEN	X	N.t.R.
* LIVER	X	N.t.R.
* THYMUS	X	N.t.R.
* TRACHEA	X	N.t.R.
* LUNGS	X	N.t.R.
* HEART	X	N.t.R.
* KIDNEYS	X	N.t.R.
* URINARY BLADDER	X	N.t.R.
* OVARIES	X	N.t.R.
* UTERUS	X	N.t.R.
* TREATMENT AREA (Skin)	X	N.t.R
* ADRENALS	X	N.t.R.
* PANCREAS	X	N.t.R.
PARTICULARS. None

FEMALES	D0	D2			D2-D0	D7	D7-D0		D14	D14-D0
Rf 0721	214	224			10	266	52		282	68
Rf0722	213	220			7	250	37		278	65
Rf 0723	206	214			8	244	38		256	50
Rf 0738	220	235			15	251	31		275	55
Rf 0739	212	227			15	254	42		258	46
Rf 0740	224	242			18	269	45		279	55
MEAN	214.8	227.0			12.2	255.7	40.8		271.3	56.5
Standard deviation	6.3		10.2	4.4		9.8	7.3	11.3			8.5