Reaction mass of 1-chlorobut-2-ene and 3-chlorobut-1-ene

Endpoint summary

Description of key information

The LD50 of the available fully reliable acute oral toxicity study (according to OECD 401) was derived at 385 mg/kg bw.

Additionally, information from TSCA 8e section provides an LC50 of ca. 4410 ppm.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study was performed prior to OECD guideline and GLP but follows principles thereof.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

no

GLP compliance:

no

Remarks:

prior to GLP requirements

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Bor: WISW (SPF TNO)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Weight at study initiation: male: 145 g, female 121 g
- Fasting period before study: 16h
- Housing: 1-5 animals per cage
- Diet (e.g. ad libitum): R10, Ssniff
- Water: libitum
- Acclimation period: 4-8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 1°C
- Humidity (%): 60 +- 5%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

petrolatum

Details on oral exposure:

VEHICLE
details not given


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

251, 316, 398, 501, 631 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs up to 6h and then daily body weight day 1, 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight:

Statistics:

LD50 determination according to Litchfield and Wilcoxon, 95% confidence interval

Sex:

male/female

Dose descriptor:

LD50

Effect level:

385 mg/kg bw

95% CL:

324 - 488

Mortality:

males/females (out of 5)
251 mg/kg bw: 0/0
316 mg/kg bw: 1/0
398 mg/kg bw: 3/3
501 mg/kg bw: 4/5
631 mg/kg bw: 5/5
Death occurred within 24-48 hours post application

Clinical signs:

other: No macroscopic changes were seen at necropsy. Clinical symptoms included diarrhoea, ataxia, staggered gait, hunched posture, sedation. Up to ten days after treatment the animals showed signs of intoxication.

Gross pathology:

dead animals showed reddened mucosa in the stomach and gut, all other animals showed no signs.

Other findings:

- Potential target organs: CNS

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

Under conditions tested, the LD50 of the test substance was calculated to be 385 mg/kg body weight. Mortality is considered to be mainly due to its corrosive properties, however, clinical signs may be indicative of possible neurotoxicity.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

385 mg/kg bw

Quality of whole database:

reliable without restriction

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Information from TSCA 8e section; no full report in hand but result has impact on hazardous properties and classification and labelling of test material

Sex:

male/female

Dose descriptor:

LC50

Effect level:

16.3 mg/L air (analytical)

Other findings:

- Potential target organs: CNS

2/6 animals died in the 2990 ppm group, 3/6 in the 4410 ppm and 5/6 in the 6290 ppm group. (LC50 ca. 4410 ppm) Clinical signs: Impairment of startle response from 359 ppm. At 2990 and 4410 ppm abnormal gait, impaired mobility, changes in arousal, hunched posture, irregular respiration. Approximate LC50 in mg/l: 4410 ppm * 90.55/24.45 * 1000 = 16.3 mg/l

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

2/6 animals died in the 2990 ppm group, 3/6 in the 4410 ppm and 5/6 in the 6290 ppm group. (LC50 ca. 4410 ppm)
Clinical signs: Impairment of startle response from 359 ppm. At 2990 and 4410 ppm abnormal gait, impaired mobility, changes in arousal, hunched posture, irregular respiration. Approximate LC50 in mg/l: 4410 ppm * 90.55/24.45 * 1000 = 16.3 mg/l

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

4 410 ppm air

Quality of whole database:

abstract information from TSCA 8e

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the results obtained the submission substance has to be classified as acute orally toxic and toxic by inhalation Cat. 4 according to Regulation (EC) No. 1272/2008 (CLP).