Trichloroacetyl chloride

Appearance / physical state / colour

Administrative data

Endpoint:

appearance / physical state / colour

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Report date: 16 December 1980 and 9 April 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Report date: 9 April 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Purity of the test item is not indicated.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA CREDO breeding center
- Females nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: 160 - 200 g
- Fasting period before study: yes, during 17 - 20h
- Housing: Cage of dimensions 37.5 x 23.5 x 16 cm (by 2 or 5) with litter of sterilized and dusted sawdust
- Diet: ad libitum, IFFARAT food
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%): 50 ± 10%
- Air changes (per hr): 8 per hour
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle (if gavage): 10 - 18 mL/kg
- Justification for choice of vehicle: no data
- Lot/batch no.: no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 18 mL/kg

DOSAGE PREPARATION: The test material is dissolved in the vehicle.

Doses:

1000, 1200, 1500, 1600 and 1800 mg/kg

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on all animals at 1, 2, and 6 hours after dosing and on Days 1, 2, 4, 7 and 14. The body weight was recorded on Days 0, 1, 2, .4, 7 and 14.
- Necropsy of survivors performed: no

Statistics:

Yes, Probit method, Litchfield and Wilcoxon method and Arcsinus method

Preliminary study:

3 groups of 4 animals (2 males and 2 females) received by oral route the test material at these doses: 1000, 2500 and 5000 mg/kg after a fasting period of 18 hours.
The test material is dissolved in arachis oil at a concentration of 25%.
The animals was observed and the mortality was recorded after the treatment and during the 14 days after the treatment.
At 2500 and 5000 mg/kg, all animals died on Day 0. And at 1000 mg/kg, 1 animal died on Day 1.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 643 mg/kg bw

Based on:

test mat.

95% CL:

> 1 552 - < 1 740

Mortality:

At 1000 and 1200 mg/kg, there was no mortality. 
At 1500 mg/kg, one female died and the autopsy revealed hemorrhagic lesions onto lungs and stomach.
At 1600 mg/kg, 4 females died between Day 1 and 2 and one male at Day 12. At the autopsy, animals presented hemorrhagic lesions onto lungs and stomach. For the male died at Day 12, the autopsy revealed  that the stomach was joint to the peritoneum, kidney were granular and  hemorrhagic aspect, thymic involution.
At 1800 mg/kg, 8 animals died. Autopsies revealed hemorrhagic stomach, lungs and thymus.

Clinical signs:

other: At 1000, 1200 mg/kg and 1500 mg/kg, 1 to 6 hours after treatment animals presented prostation, apathy, and had a reduce spontaneous activity. At  day 1, all the animals exposed at doses of 1000 and 12000 mg/kg presented no abnormalities, but apathy and pr

Table 1: Cumulated mortality

Administration			Animals		Cumulated mortality
Dose mg/kg	Volume mL/kg	Concentration %	Weight g	Number	1 hour	2 hours	6 hours	1 day	2 days	4 days	7 days	14 days	%
Control	18	Arachis oil	M 156	5	0	0	0	0	0	0	0	0	0
			F 150	5	0	0	0	0	0	0	0	0
1000	10	10	M 155	5	0	0	0	0	0	0	0	0	0
			F 155	5	0	0	0	0	0	0	0	0
1200	12	10	M 152	5	0	0	0	0	0	0	0	0	0
			F 150	5	0	0	0	0	0	0	0	0
1500	15	10	M 156	5	0	0	0	0	0	0	0	0	10
			F 151	5	0	0	0	0	0	0	0	0
1600	16	10	M 176	5	0	0	0	0	0	0	0	1	50
			F 168	5	0	0	0	3	4	4	4	4
1800	18	10	M 155	5	0	0	0	2	3	4	4	4	80
			F 148	5	0	0	0	3	4	4	4	4

LD50 according to:

-      Probit: 1643 mg/kg (1566 – 1723 mg/kg)

-      Litchfield & Wilcoxon: 1643 mg/kg (1552 – 1740 mg/kg)

-      Arcsinus: 1647 mg/kg (1577 – 1721 mg/kg)

Table 2: Body weight gain

a) Males

Sex	Dose mg/kg		Mean body weight (g)
			Day 0	Day 1	Day 2	Day 4	Day 7	Day 14
Males	Control	n m s	5 156 3.11	5 174 2.88	5 178 2.51	5 194 4.09	5 217 3.42	5 259 10.09
	1000	n m s t	5 155 5.94 - 0.40	5 150 7.06 - 6.81*	5 164 5.77 - 4.69*	5 179 8.47 - 3.71*	5 203 6.76 - 4.13*	5 258 13.39 - 0.21
	1200	n m s t	5 152 6.86 - 1.13	5 145 6.46 - 9.16*	5 153 7.69 - 6.85*	5 169 7.09 - 6.99*	5 191 6.80 - 7.57*	5 251 10.94 - 1.29
	1500	n m s t	5 156 2.86 0.21	5 149 4.60 - 10.04*	5 153 6.40 - 7.80*	5 171 3.96 - 9.04*	5 193 4.56 - 9.65*	5 255 17.21 - 0.79
	1600	n m s t	5 176 / /	5 157	5 157	5 170	5 161	4 250
	1800	n m s t	5 155 / /	3 139	2 137	1 163	1 184	1 250

b) Females

Sex	Dose mg/kg		Mean body weight (g)
			Day 0	Day 1	Day 2	Day 4	Day 7	Day 14
Females	Control	n m s	5 150 3.77	5 166 2.49	5 169 2.19	5 181 1.87	5 187 1.14	5 221 6.23
	1000	n m s t	5 155 4.72 1.63	5 155 5.22 - 5.49*	5 164 7.09 - 1.75	5 177 4.22 - 2.13	5 187 5.10 - 0.17	5 215 8.00 0.57
	1200	n m s t	5 150 6.50 0.00	5 137 3.63 - 14.72*	5 147 10.42 - 4.71*	5 164 6.40 - 5.70*	5 178 6.12 - 3.37*	5 205 6.11 - 1.79
	1500	n m s t	5 151 6.46 0.18	5 141 7.16 - 7.19*	4 149 17.39 - 2.71*	4 163 17.52 - 2.39*	4 181 15.46 - 0.98	4 212 21.28 - 1.52
	1600	n m s t	5 168 / /	2 148	1 147	1 181	1 194	1 215
	1800	n m s t	5 148 / /	2 137	1 153	1 168	1 185	1 212

n: number of survivors

m: mean

s: standard deviation

*: significant test t at the threshold of 95%

/: no information on this sigle in the report

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

In these test conditions, the acute oral LD50 value of Trichloroacetyl chloride was 1643 mg/kg according to Probit method or Litchfield and Wilcoxon method.

Executive summary:

The study was performed to assess the acute oral toxicity of Trichloroacetyl chloride (TCAC) in the rat. The method followed was similar to the OECD Guideline 401 and the study was not performed in accordance with GLP.

TCAC was administered to five Sprague-Dawley rats of each sex. The animals were exposed to single oral dose levels of 1000, 1200, 1500, 1600 and 1800 mg/kg. All animals were subjected to observations and determination of body weight. Macroscopic examination was performed on the day of death. At 1800 mg/kg, 8 animals died. Autopsies revealed hemorrhagic stomach, lungs and thymus. At 1600 mg/kg, 4 females died between Day 1 and 2 and one male at Day 12. At the autopsy, animals presented hemorrhagic lesions onto lungs and stomach. For the male died at Day 12, the autopsy revealed that the stomach was joint to the peritoneum, kidney were granular and hemorrhagic aspect, thymic involution. At 1500 mg/kg, one female died and the autopsy revealed hemorrhagic lesions onto lungs and stomach. At 1000 and 1200 mg/kg, there is no mortality.

The acute oral LD50 value of TCAC was 1643 mg/kg according to Probit method or Litchfield and Wilcoxon method.

In these test conditions, TCAC is classified harmful if swallowed according to the UN GHS and CLP criteria.

Cross-reference 2

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Report date: 9 April 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Purity of the test material is not indicated and the study was performed under occlusive conditions.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

occlusive conditions.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA CREDO breeding center
- Females nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: 165 - 172 g
- Fasting period before study: yes, during 17 - 20h
- Housing: Cage of dimensions 37.5 x 23.5 x 16 cm (by 2 or 5) with litter of sterilized and dusted sawdust
- Diet: ad libitum, IFFARAT food
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%): 50 ± 10%
- Air changes (per hr): 8 per hour
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: bandage consisting of a sheet of aluminum foil and strip of adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.23 mL/kg
- Concentration (if solution): prodcut as is
- Constant volume used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

10 (5 males and 5 females)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations (mortality and behaviour) and weighing: Clinical observations were performed on all animals at 1, 2, and 6 hours after dosing and on Days 1, 2, 4, 7 and 14. The body weight was recorded on Days 0, 1, 2, .4, 7 and 14.
- Necropsy of survivors performed: no

Statistics:

Yes, Probit method, Litchfield and Wilcoxon method and Arcsinus method

Preliminary study:

2 groups of 4 animals (2 males and 2 females) received by dermal route the test material at these doses: 1000 and 2000 mg/kg (volume: 0.62 and 1.23 mL/kg, respectively). The test material was applied as such.
The animals were observed and the mortality was recorded after the treatment and during the 14 days after the treatment.
At 1000 and 2000 mg/kg, there was no mortality.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred at the dose level of 2000 mg/kg.

Clinical signs:

other: There was no clinical sign.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities except cutaneous reactions (see below).

Other findings:

Local tolerance:
Day 1: Increase of dermal thickness on application site.
Day 4: Skin lesions on the back of animals.
Day 7: purulent lesions.
Day 14: persistence of skin lesions.

Table 1: Mortality

Administration			Animals		Cumulated mortality
Dose mg/kg	Volume mL/kg	Concentration %	Weight g	Number	1 hour	2 hours	6 hours	1 day	2 days	4 days	7 days	14 days	%
Control	-	-	M 168	5	0	0	0	0	0	0	0	0	0
			F 165	5	0	0	0	0	0	0	0	0
2000	1.23	Product as such	M 172	5	0	0	0	0	0	0	0	0	0
			F 171	5	0	0	0	0	0	0	0	0

 

Table 2: Body weight gain

Sex	Dose mg/kg		Mean body weight (g)
			Day 0	Day 1	Day 2	Day 4	Day 7	Day 14
Males	Control	n m s	5 168 5.15	5 153 7.92	5 165 4.27	5 180 5.45	5 210 4.76	5 264 6.60
	2000	n m s t	5 172 7.95 0.90	5 157 8.76 0.68	5 161 8.99 1.03	5 172 11.20 - 1.47	5 198 8.57 - 2.78*	5 238 11.48 - 4.45*
Females	Control	n m s	5 165 6.38	5 161 8.58	5 166 7.89	5 176 7.23	5 193 6.88	5 217 4.44
	2000	n m s t	5 171 7.40 1.37	5 162 7.40 0.20	5 161 6.80 - 1.11	5 171 10.90 - 0.72	5 190 12.84 - 0.58	5 213 9.52 - 0.85

n: number of survivors

m: mean

s: standard deviation

*: significant test t at the threshold of 95%

Interpretation of results:

other: Not classified

Conclusions:

In these test conditions, the acute dermal LD50 value of Trichloroacetyl chloride was found to be higher to 2000 mg/kg.

Executive summary:

The study was performed to assess the acute dermal toxicity of Trichloroacetyl chloride (TCAC) in the rat. The method followed was similar to OECD Guideline 402 and the study was not performed in accordance with GLP.

Ten animals (5 males and 5 females) were exposed to single dermal dose level of 2000 mg/kg. All animals were subjected to observations and determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred at the dose level of 2000 mg/kg and there was no clinical sign. Macroscopic examination of the main organs of the animals revealed no apparent abnormalities except cutaneous reactions (Day 7: purulent lesions - Day 14: persistence of skin lesions).

The acute dermal LD50 value of TCAC was higher to 2000 mg/kg.

In these test conditions, TCAC is not classified according to the UN GHS and CLP criteria.

Cross-reference 3

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Report date: 16 December 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Purity of the test item is not indicated.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive dressing, 24 hours for duration of treatment, only 72 hours of observation period

GLP compliance:

no

Species:

rabbit

Strain:

other: New Zealand

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 to 3.5 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
No data are available.

IN-LIFE DATES: From: 20 November 1980 To: 23 November 1980

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

Concentration: 0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: disc of 3 cm diameter
- % coverage: no data
- Type of wrap if used: adhesive tape and pansement

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

OBSERVATION TIME POINTS
25 hours (= 1 hour after removal of the tape) and 72 hours after application

SCORING SYSTEM:
* Erythema and eschar formation:
No erythema = 0
Very slight erythema (barely perceptible) = 1
Slight erythema (perceptible) = 2
Moderate to severe erythema = 3
Severe erythema and with eschar formation:
* slight eschar = 4
* extended eschar (more than 50% of the surface application) = 8

* Oedema formation:
No oedema = 0
Very slight oedema (barely perceptible) = 1
Slight oedema (edges of area well-defined by definite raising) = 2
Moderate oedema (raised approximately 1 millimetre) = 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) = 4

The numerical rating scale above allows the determination of a "Primary Skin Irritation Index"; this index is equal to the sum of the individual values which express the intensity of the erythema and the intensity of the edema, 25 hours and 72 hours after the application, both on the intact skin and on the scarified skin, divided by 16 (number of treated rabbits x 4). The maximum value of the primary skin irritation index is 12.

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 25 and 72 hours

Score:

8.63

Reversibility:

not specified

Irritant / corrosive response data:

All animals presented a well visible erythema exceeding the application area at time 25 hours.
- Normal area:
All animals presented oedema and erythema (scored 3, 4 or 8) at time 25 and 72 hours. One rabbit presented an extended eschar at time 25 hours and a very important necrosis at time 72 hours.

- Scarified area:
All animals presented oedema and erythema (scored 3, 4 or 8) at time 25 and 72 hours. One rabbit presented a very important necrosis at time 72 hours.

Table 2: Results

Evaluation of irritation
Rabbits n°	Areas	25 hours			72 hours			Total
		Erythema	Oedema	Total	Erythema	Oedema	Total	(25 + 72h) Er. + oed.
585	normal	4*	4	8	^G4	3	7	15
	scarified	4*	4	8	^G4	3	7	15
586	normal	4	4	8	^G4	4	8	16
	scarified	4*	4	8	^G4	4	8	16
587	normal	4*	4	8	^G4*	4	8	16
	scarified	4*	4	8	^G4*	4	8	16
585	normal	8	4	12	8^+	4	12	24
	scarified	4	4	8	8^+	4	12	20

*: Erythema without eschar

^G: Skin of greyish appearance on a zone superior to that of the application

⁺: Very important necrosis with bleeding well beyond the area of the application

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

In these test conditions, Thrichloroacetyl chloride is considered as corrosive to skin.

Executive summary:

A skin irritation study was performed with Trichloroacetyl chloride (TCAC) in rabbits. The method followed was similar to the OECD Guideline 404 and the study was not performed in accordance with GLP. TCAC was applied on scarified or normal skin for 24 hours under occlusive coverage. Examinations were performed at 25 hours (1 hour after removal of the tape) and 72 hours after application. Erythema (and eschar) and oedema formation were scored. All animals presented a well visible erythema exceeding the application area at time 25 hours. All animals presented oedema and erythema (scored 3, 4 or 8) at time 25 and 72 hours. One rabbit presented a very important necrosis at time 72 hours.

TCAC is classified corrosive to skin according to the UN GHS and CLP criteria.

Cross-reference 4

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Report date: 16 December 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Purity of the test item is not indicated.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

4 animals, observation period of 7 days

GLP compliance:

no

Species:

rabbit

Strain:

other: New Zealand

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.0 to 3.0 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
No data are available.

IN-LIFE DATES: From: 27 November 1980 To: 4 December 1980

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye, which remained untreated, served as control

Amount / concentration applied:

Amount applied: 0.1 mL introduced into the conjunctival sac of the left eye

Duration of treatment / exposure:

Single conjunctival instillation

Observation period (in vivo):

1 hour and 1, 2, 3, 4 and 7 days after the administration

Number of animals or in vitro replicates:

4 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

SCORING SYSTEM:
Conjonctivae
A = chemosis (oedema)
- none = 0
- slight = 1
- pronounced, with eversion of the eyelids = 2
- with half-closed eyelids = 3
- with closed or almost closed eyelids = 4

B = lacrimal secretions
- none = 0
- slight = 1
- with moistening of the hairs around the eyelids = 2
- same observation, but on large surfaces around the eye = 3

C = redness of the palpebral conjunctiva
- normal appearance = 0
- vessels significantly more injected than normal = 1
- diffuse redness with vessels difficult to individualize = 2
- color dark red diffuse = 3

Iris
A1 = damage of this iris
- normal appearance = 0
- aspect much more pleated than normal, congestion, swelling, circumcorneal injections (or only one of these manifestations), but iris still reacting to light (even weakly or slowly) = 1
- no reaction to light, hemorrhage, significant destruction (or only one of these manifestations) = 2

A2 = degree of opacity
- normal appearance = 0
- loss of shine or polish, but clearly visible iris details = 1
- translucent area, with slightly obscured iris details = 2
- opalescent area, with invisible iris details and barely visible pupil contour = 3
- iris and pupil invisible = 4

B2 = surface of the opacity
- less than or equal to a quarter (but not zero) = 1
- between one-quarter and one-half = 2
- between one-half and three quarters = 3
- more than three quarters = 4

The coefficients of the conjunctival damage, the iris damage and the corneal damage allow to determine 3 indices of ocular irritation:
- the individual eye irritation index (= IEI), the maximum value of which equals 110, is equal to eacg time, for each rabbit, to
2 (A + B + C) + 5A1 + 5A2B2
- the mean ocular irritation index (= MOI) is the average, at each time, of the IEI of the 4 treated rabbits;
- the acute eye irritation index (= AEI) is the highest MOI obtained within 7 days of observation.

The interpretation of the results is made from these 3 index and is drawn from KAY and CALANDRA (J. Soc. Cosmet. Chem., 13, 281 (1962): "Interpretation of eye-irritation tests").

Irritation parameter:

other: Mean ocular irritation score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

importance of the effects

Irritation parameter:

other: Mean ocular irritation score

Basis:

mean

Time point:

7 d

Score:

90.67

Reversibility:

not reversible

Irritant / corrosive response data:

The importance of injuries did not allow calculating mean scores for chemosis, corneal opacity and iritis.
Observations: Conjunctival chemosis (grade 4) were observed in all  animals at 1h and remained present at the end of the observation study (day 7). Corneal opacity was observed in all of the animals and remained  present at day 1 and day 2 to day 7 the observation of corneal opacity was impossible because of severe chemosis. One rabbit presented a necrose on day 7.

Table 1: Results

Evaluation of effects		1 hour				Day 1				Day 2
N° of rabbits		757	758	759	760	757	758	759	760	757	758	759	760
Conjunctiva	A) Chemosis 0 - 4	4	4	4	4	4	4	4	4	4	4	4	4
	B) Discharge 0 - 3	1	1	1	1	2	2	2	2	2	2	2	2
	C) Enanthema 0 - 3	?	?	?	?	?	?	?	?	?	?	?	?
	(A+B+C) x 2 (max. = 20)	≥ 10	≥ 10	≥ 10	≥ 10	≥ 12	≥ 12	≥ 12	≥ 12	≥ 12	≥ 12	≥ 12	≥ 12
Direct photomotor reflex of pupil (§)		ɸ	ɸ	ɸ	ɸ	ɸ	ɸ	ɸ	ɸ	¥	¥	¥	¥
Iris	Congestion 0 – 2	ɸ	ɸ	ɸ	ɸ	ɸ	ɸ	ɸ	ɸ	¥	¥	¥	¥
	x 5 (max. = 10)	ɸ	ɸ	ɸ	ɸ	ɸ	ɸ	ɸ	ɸ	¥	¥	¥	¥
(§) N = Normal – R = Reduced – No reflex
Cornea	A) Opacity 0 – 4	4	4	4	4	4	4	4	4	¥	¥	¥	¥
	B) Area affected 1 – 4	α	α	α	α	α	α	α	α	¥	¥	¥	¥
	A x B x 5 (max. = 80)	α	α	α	α	α	α	α	α	¥	¥	¥	¥
Individual ocular irritation score IEI (max. 110)		/	/	/	/	/	/	/	/	/	/	/	/

Observations:

?: the palpebral conjunctiva presented a blackish appearance not allowing the observation of the enanthema.

ɸ: the degree of corneal opacification did not allow observation of the iris.

α: the degree of chemosis allowed the observation of only a small part of the corneal surface; only the degree of opacification could be estimated.

¥: the degree of chemosis made reading impossible.

/: the significance of the damages does not allow calculating a value for this index.

Mean score per zone	Conj. + Iris + Corn.			Conj. + Iris + Corn.			Conj. + Iris + Corn.
	≥ 10.00	/	/	≥ 12.00	/	/	≥ 12.00	/	/
Mean ocular irritation score MOI Standard deviation S		/			/			/

 

Evaluation of effects		Day 3				Day 4				Day 7
N° of rabbits		757	758	759	760	757	758	759	760	757	758	759	760
Conjunctiva	A) Chemosis 0 - 4	4	4	4	4	4	4	4	4	4	4	4	4
	B) Discharge 0 - 3	2	2	2	2	1	2	2	2	1	1	2	2
	C) Enanthema 0 - 3	?	?	?	?	¥	¥	¥	¥	¥	¥	¥	¥
	(A+B+C) x 2 (max. = 20)	≥ 12	≥ 12	≥ 12	≥ 12	≥ 10	≥ 12	≥ 12	≥ 12	≥ 10	≥ 10	≥ 12	≥ 12
Direct photomotor reflex of pupil (§)		¥	¥	¥	¥	¥	¥	¥	¥	¥	¥	¥	Ӿ
Iris	Congestion 0 – 2	¥	¥	¥	¥	¥	¥	¥	¥	¥	¥	¥	Ӿ
	x 5 (max. = 10)	¥	¥	¥	¥	¥	¥	¥	¥	¥	¥	¥	Ӿ
(§) N = Normal – R = Reduced – No reflex
Cornea	A) Opacity 0 – 4	¥	¥	¥	¥	¥	¥	¥	¥	4^+	4^+	4^+	Ӿ
	B) Area affected 1 – 4	¥	¥	¥	¥	¥	¥	¥	¥	4	4	4	Ӿ
	A x B x 5 (max. = 80)	¥	¥	¥	¥	¥	¥	¥	¥	80	80	80	Ӿ
Individual ocular irritation score IEI (max. 110)		/	/	/	/	/	/	/	/	≥ 90	≥ 90	≥ 92	/

Observations:

?: the palpebral conjunctiva presented a blackish appearance not allowing the observation of the enanthema.

¥: the degree of chemosis made reading impossible.

⁺: the degree and the surface of corneal opacification were determined after the sacrifice of the animal.

Ӿ: at the opening of the eyelids, total necrosis of the treated eye was observed.

/: the significance of the damages does not allow calculating a value for this index.

Mean score per zone	Conj. + Iris + Corn.			Conj. + Iris + Corn.			Conj. + Iris + Corn.
	≥ 12.00	/	/	≥ 11.50	/	/	≥ 10.67	/	80.00
Mean ocular irritation score MOI Standard deviation S		/			/			≥ 90.67 1.15

                                                                                                                                            Mean calculated on 3 rabbits

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Under the test conditions, Trichloroacetyl chloride is considered as highly irritant.

Executive summary:

An eye irritation study was performed with Trichloroacetyl chloride (TCAC) in rabbits. The method followed was similar to the OECD Guideline 405 and the study was not performed in accordance with GLP. A single dose of TCAC in its originak form was introduced into the conjunctival sac of the left eye. The right eye was not treated and served as control. The eyes were not rinsed after administration of TCAC.

Ocular reactions were observed 1 hour and 1, 2, 3, 4 and 7 days after the administration.

The importance of injuries did not allow calculating mean scores for chemosis, corneal opacity and iritis.

Conjunctival chemosis (grade 4) were observed in all  animals at 1h and remained present at the end of the observation study (day 7). Corneal opacity was observed in all of the animals and remained  present at day 1 and day 2 to day 7 the observation of corneal opacity was impossible because of severe chemosis. One rabbit presented a necrose on day 7.

TCAC is classified corrosive to eyes according to the UN GHS and CLP criteria.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Principles of method if other than guideline:

No data

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Test material form:

liquid

Details on test material:

Name of the test material in the report: Chlorure de trichloracetyle

Results and discussion

Physical state at 20°C and 1013 hPa:

liquid

Form / colour / odour

Key result

Form:

liquid

Colour:

colorless

Odour:

other: no determined

Substance type:

organic

Applicant's summary and conclusion

Conclusions:

Trichloroacetyl chloride is an organic colourless liquid.

Executive summary:

Trichloroacetyl chloride is an organic colourless liquid.