3-chloropropionyl chloride

Endpoint summary

Description of key information

The test substance was concluded to be corrosive to the skin and causing irreversible damage to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, non guideline study, available as unpublished report, restrictions in design and/or reporting but otherwise adequate for assessment.

Principles of method if other than guideline:

The test substance was applied to white Vienna rabbits for 1 min, 5 min, 15 min and 20 h under occlusive conditions. The skin was left intact. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24 hours and at the end of the observation period. Findings were graded as described in OECD test guideline 404.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.47 and 2.8 kg

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 mL

Duration of treatment / exposure:

1, 5, 15 minutes and 20 hours

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- % coverage: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol:water (1:1)

SCORING SYSTEM: equivalent to the scoring system described in OECD 404

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 hour

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 1 minute exposure

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 hour

Score:

2

Max. score:

4

Remarks on result:

other: 1 minute exposure. Slight scaling at day 8

Irritation parameter:

edema score

Basis:

animal: #1 and #2

Time point:

other: 24 hour

Score:

0

Max. score:

4

Remarks on result:

other: 1 minute exposure

Irritation parameter:

erythema score

Basis:

animal: #1 and #2

Time point:

other: 24 hour

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days.

Remarks on result:

other: 5 minutes exposure. Effect observed arround test-patch. Necrosis was observed within 24 hour.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 hour

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 5 minutes exposure

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24 hour

Score:

0

Max. score:

4

Remarks on result:

other: 5 minute exposure

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 hour

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: 15 minutes exposure. Effect observed arround test-patch. Necrosis was observed within 24 hour.

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 hour

Score:

0

Max. score:

4

Remarks on result:

other: 15 minutes exposure. Necrosis was observed within 24 hour.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 hour

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 15 minutes exposure

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24 hour

Score:

0

Max. score:

4

Remarks on result:

other: 15 minutes exposure

Irritation parameter:

erythema score

Basis:

animal: #1 and #2

Time point:

other: 24 hour

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 20 hour exposure. Effect observed arround test-patch. Necrosis was observed within 24 hour.

Irritation parameter:

edema score

Basis:

animal: #1 and #2

Time point:

other: 24 hour

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 20 hour exposure

Irritant / corrosive response data:

Full thickness necrosis of the skin was observed after exposure for 5 and 15 minutes as well as after 20 hours at the end of the observation period.
Necrosis was already observed at the 24 h reading (5 and 15 minutes, 20 hours).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, non guideline study, available as unpublished report, restrictions in design and/or reporting but otherwise adequate for assessment.

Principles of method if other than guideline:

The test substance (0.05 mL) was applied to the conjunctival sac of white Vienna rabbits. The non-treated adjacent eye served as control, to which NaCl was applied. The animals were observed several times on the treatment day and 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 hours after substance application. Findings were graded as described in OECD test guideline 405.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.05 and 2.13 kg

Vehicle:

unchanged (no vehicle)

Controls:

other: eye of the same animals treated with NaCl

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 mL

Duration of treatment / exposure:

single application

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

SCORING SYSTEM: equivalent to the scoring system described in OECD 405 guideline.

Irritation parameter:

cornea opacity score

Basis:

animal: #1 and #2

Time point:

other: 24 hours

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: Severe chemical burns and corneal opacity was observed throughout the study

Irritation parameter:

chemosis score

Basis:

animal: #1 and #2

Time point:

other: 24 hour

Score:

0

Max. score:

3

Irritant / corrosive response data:

Within one hour after application the first signs of corrosion were visible in combination with slight edema. Within 24 hours corrosion was observed. The tissue underneath the eye was severely damaged. After 8 days corrosion in combination with strong supperation.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In a skin irriation/corrosion test, the test substance was applied to two white Vienna rabbits for 1 min, 5 min, 15 min and 20 h under occlusive conditions (1968; RL2). The skin was left intact. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24 hours and at the end of the observation period. Findings were graded as described in OECD test guideline 404. Full thickness necrosis of the skin was observed after exposure for 5 and 15 minutes as well as after 20 hours at the end of the observation period. Necrosis was already observed at the 24 h reading (5 and 15 minutes, 20 hours). Even though necrosis was not observed following one minute application, it cannot be rules out that 3 minutes applications does not induce necrosis. Hence, as a worst case assumption, the substance is considered Category 1A.

Eye irritation

In a eye irritation/corrosion test, the test substance (0.05 mL) was applied to the conjunctival sac of two white Vienna rabbits (1968; RL2). The non-treated adjacent eye served as control, to which NaCl was applied. The animals were observed several times on the treatment day and 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 hours after substance application. Findings were graded as described in OECD test guideline 405. Within one hour after application the first signs of corrosion were visible in combination with slight edema. Within 24 hours corrosion was observed. The tissue underneath the eye was severely damaged. After 8 days corrosion in combination with strong supperation was observed.

Justification for classification or non-classification

Based on the severity and irreversibility of the observed effects, the test substance is classified as Skin corrosive category 1A, H314: Causes severe skin burns and eye damage in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.

Because severe eye effects were observed after ocular application, the test substance has to be classified as Eye damage 1: H318: Causes serious eye damage in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.