1,3-Cyclohexanedimethanamine

Endpoint summary

Description of key information

Corrosive effects seen in albino rabbit following 3 minutes' dermal exposure.  Substance is therefore considered corrosive and eye irritation studies subsequently considered unjustified.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 April 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to GLP and internationally accepted test guidelines.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: twelve to sixteen weeks
- Weight at study initiation: 2.91 kg
- Housing: individually housed in a suspended metal cage.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21°C
- Humidity (%): 65%
- Air changes (per hr): fifteen per hour
- Photoperiod (hrs dark / hrs light):12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml


TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml

Duration of treatment / exposure:

3 minutes

Observation period:

1 hour

Number of animals:

1

Details on study design:

TEST SITE
- Area of exposure: 3 sites, each 2.5 cm x 2.5 cm
- Type of wrap if used: BLENDERM (2.5 cmx 4.0cm ) tape to hold cotton gauze over application site and TUBIGRIP elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): site washed with distilled water
- Time after start of exposure: 3 minutes, all patches were removed at that time.

SCORING SYSTEM:
Erythema and Eschar Formation: No erythema, 0; very slight erythema (barely perceptible, 1; Well-defined erythema, 2; moderate to severe erythema, 3; severe erythema (beet redness) to slight eschar formation (injuries in depth), 4.

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.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1 hour

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: The animal was killed for humane reasons following the 1-hour observation

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Reversibility:

other: not applicable

Remarks on result:

other: erythema scores considered to be of low relevance due to severe necrosis early in the test.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1 hour

Score:

0

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: The animal was killed for humane reasons following the 1-hour observation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Reversibility:

other: not applicable

Remarks on result:

other: edema scores considered to be of low relevance due to severe necrosis early in the test.

Irritant / corrosive response data:

Green coloured necrosis was noted over the whole of the test site at the 1-hour observation. A loss of elasticity and drying of the skin was also noted. The animal was killed for humane reasons following the 1-hour observation in accordance with current UK Home Office guidelines and Safepharm company policy.

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Conclusions:

The test material, 1,3-BAC, was classified as CORROSIVE to rabbit skin according to EU labeling regulations.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992) and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

A single 3-minute semi-occluded application of the test material to the intact skin of one rabbit produced corrosive effects.

4-hour and 1-hour semi-occluded applications of the test material to the intact skin were therefore not investigated.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

March 8 through April 3 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study not performed to GLP and test parameters do not comply with specific test guidelines but investigations are well documented and scientifically acceptable.

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

other: The United Nations test methods and evaluation criteria in the evaluation of danger of unkown substances, established by the Maritime Techniques Safety Bureau, Ministry of Transport

GLP compliance:

not specified

Species:

rat

Strain:

other: Crj-Wistar

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 5 weeks
- Diet (e.g. ad libitum): freely given solid diet MF (Oriental Yeast Industries Co., Ltd)
- Water (e.g. ad libitum): freely given
- Acclimation period:8 days



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2
- Humidity (%): 55 +/- 6

Type of coverage:

open

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):1 ml/kg

Duration of treatment / exposure:

4 hours

Number of animals:

Animals used in the test amounted to 12, including 3 male and 3 female rats and 3 male and 3 female mice . These animals were confirmed to be in good health and skin condition and to have almost the same body weights by sex and species.

Details on study design:

TEST SITE
- Area of exposure: 1 cm2/head

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

SCORING SYSTEM: Er=erythema; Ed= edema; H=hemorrhage; N=necrosis Severity: 0= normal; 1= very mild; 2= mild; 3= moderate; 4=severe

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

male rat

Time point:

other: 3 min

Score:

1

Max. score:

4

Reversibility:

no data

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

male rat

Time point:

other: 3 minutes

Score:

0

Max. score:

4

Reversibility:

no data

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

male rat

Time point:

other: 3 minutes

Score:

0

Max. score:

4

Reversibility:

no data

Irritation parameter:

other: Hemorrhage

Basis:

animal #1

Remarks:

male rat

Time point:

other: 3 minutes

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: hemmorhage

Basis:

animal #2

Remarks:

male rat

Time point:

other: 3 minutes

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: hemmorhage

Basis:

animal #3

Remarks:

male rat

Time point:

other: 3 minutes

Score:

1

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: necrosis

Basis:

animal #1

Remarks:

male rat

Time point:

other: 3 minutes

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: necrosis

Basis:

animal #2

Remarks:

male rat

Time point:

other: 3 minutes

Score:

1

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: necrosis

Basis:

animal #3

Remarks:

male rat

Time point:

other: 3 minutes

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: hemmorhage

Basis:

mean

Remarks:

all animals, male/female, rats and mice

Time point:

other: 60 minues

Score:

4

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: necrosis

Basis:

mean

Remarks:

all animals (male/female) (rats and mice)

Time point:

other: 4 hours

Score:

4

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

Severity: 0= normal; 1= very mild; 2= mild; 3= moderate; 4=severe

The results of observation of dermal symptoms at 3 minutes, 60 minutes and 4 hours after application are illustrated in Table 1. In rats, the skin surfaces changed color (dark brown) and subcutaneous hemorrhage occurred from 1.5 minutes after application; these lesions were further aggravated as they were macroscopically judged to be necrosis after 3 minutes. The skin surfaces manifested highly necrotic appearances after 60 minutes; namely, dark red brown lesions were slightly dried and hardened.

In the observation of cut surfaces of the skin at 4 hours after application, necrosis appeared throughout the entire dermal layers and hemorrhage as severe as it reached the dorsal muscle.

Er=erythema; Ed= edema; H=hemorrhage; N=necrosis Severity: 0= normal; 1= very mild; 2= mild; 3= moderate; 4=severe

Table. Primary irritative symptoms in the skin

Animal	Sex	Animal No.	Body Weight (g)	3 mins.				60 mins.				4 hr.
				Er	ED	H	N	Er	ED	H	N	Er	ED	H	N
Crj Wistar rats (6 weeks)	Male	1	205	1	0	2	2	0	0	4	4	0	0	4	4
		2	201	0	0	2	2	0	0	4	4	0	0	4	4
		3	203	0	0	1	2	0	0	4	4	0	0	4	4
	Female	4	154	2	0	1	2	0	0	4	4	0	0	4	4
		5	157	0	0	1	2	0	0	4	4	0	0	4	4
		6	150	0	0	2	2	0	0	4	4	0	0	4	4

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: other: UN IMO 1985

Conclusions:

According to test guideline under which this study was conducted, the evaluation for dermal corrosiveness of unknown substances are classified by Package Grades. The test substance was judged, based on the given criteria, to correspond to a corrosive substance, Package Grade I, a substance that causes necrosis at the contact site when brought into contact with the skin of an animal within 3 minutes.

Executive summary:

A skin corrosive test founded on the standards of the United Nations was performed in accordance with "the test methods and evaluation criteria in the evaluation of danger of unkown substances" established by the Maritime Techniques Safety Bureau, Ministry of Transport (December 1985), in order to determine whether or not 1,3 -BAC corresponded to a corrosive substance (class 8) defined in the recommendations of the United Nations concerning the transport of dangerous substances.

As a result, the test substance was judged in accordance with the criteria of the International Maritime Organization (IMO) to corespond to a corrosive substance defined in the recommendations of the United Nations concerning the transport of dangerous substances.

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

March 8 through April 3 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study not performed to GLP and test parameters do not comply with specific test guidelines but investigations are well documented and scientifically acceptable.

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

other: The United Nations test methods and evaluation criteria in the evaluation of danger of unkown substances, established by the Maritime Techniques Safety Bureau, Ministry of Transport

GLP compliance:

not specified

Species:

mouse

Strain:

other:

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 5 weeks
- Diet (e.g. ad libitum): freely given solid diet MF (Oriental Yeast Industries Co., Ltd)
- Water (e.g. ad libitum): freely given
- Acclimation period:8 days



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2
- Humidity (%): 55 +/- 6

Type of coverage:

open

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):1 ml/kg

Duration of treatment / exposure:

4 hours

Number of animals:

Animals used in the test amounted to 12, including 3 male and 3 female rats and 3 male and 3 female mice . These animals were confirmed to be in good health and skin condition and to have almost the same body weights by sex and species.

Details on study design:

TEST SITE
- Area of exposure: 1 cm2/head

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

SCORING SYSTEM: Er=erythema; Ed= edema; H=hemorrhage; N=necrosis Severity: 0= normal; 1= very mild; 2= mild; 3= moderate; 4=severe

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

male rat

Time point:

other: 3 min

Score:

1

Max. score:

4

Reversibility:

no data

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

male rat

Time point:

other: 3 minutes

Score:

0

Max. score:

4

Reversibility:

no data

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

male rat

Time point:

other: 3 minutes

Score:

0

Max. score:

4

Reversibility:

no data

Irritation parameter:

other: Hemorrhage

Basis:

animal #1

Remarks:

male rat

Time point:

other: 3 minutes

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: hemmorhage

Basis:

animal #2

Remarks:

male rat

Time point:

other: 3 minutes

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: hemmorhage

Basis:

animal #3

Remarks:

male rat

Time point:

other: 3 minutes

Score:

1

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: necrosis

Basis:

animal #1

Remarks:

male rat

Time point:

other: 3 minutes

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: necrosis

Basis:

animal #2

Remarks:

male rat

Time point:

other: 3 minutes

Score:

1

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: necrosis

Basis:

animal #3

Remarks:

male rat

Time point:

other: 3 minutes

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: hemmorhage

Basis:

mean

Remarks:

all animals, male/female, rats and mice

Time point:

other: 60 minues

Score:

4

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

other: necrosis

Basis:

mean

Remarks:

all animals (male/female) (rats and mice)

Time point:

other: 4 hours

Score:

4

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

Severity: 0= normal; 1= very mild; 2= mild; 3= moderate; 4=severe

The results of observation of dermal symptoms at 3 minutes, 60 minutes and 4 hours after application are illustrated in Table 1. In rats, the skin surfaces changed color (dark brown) and subcutaneous hemorrhage occurred from 1.5 minutes after application; these lesions were further aggravated as they were macroscopically judged to be necrosis after 3 minutes. The skin surfaces manifested highly necrotic appearances after 60 minutes; namely, dark red brown lesions were slightly dried and hardened.

In the observation of cut surfaces of the skin at 4 hours after application, necrosis appeared throughout the entire dermal layers and hemorrhage as severe as it reached the dorsal muscle.

Er=erythema; Ed= edema; H=hemorrhage; N=necrosis Severity: 0= normal; 1= very mild; 2= mild; 3= moderate; 4=severe

Table. Primary irritative symptoms in the skin

Animal	Sex	Animal No.	Body Weight (g)	3 mins.				60 mins.				4 hr.
				Er	ED	H	N	Er	ED	H	N	Er	ED	H	N
Crj Wistar rats (6 weeks)	Male	1	205	1	0	2	2	0	0	4	4	0	0	4	4
		2	201	0	0	2	2	0	0	4	4	0	0	4	4
		3	203	0	0	1	2	0	0	4	4	0	0	4	4
	Female	4	154	2	0	1	2	0	0	4	4	0	0	4	4
		5	157	0	0	1	2	0	0	4	4	0	0	4	4
		6	150	0	0	2	2	0	0	4	4	0	0	4	4

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: other: UN IMO 1985

Conclusions:

According to test guideline under which this study was conducted, the evaluation for dermal corrosiveness of unknown substances are classified by Package Grades. The test substance was judged, based on the given criteria, to correspond to a corrosive substance, Package Grade I, a substance that causes necrosis at the contact site when brought into contact with the skin of an animal within 3 minutes.

Executive summary:

A skin corrosive test founded on the standards of the United Nations was performed in accordance with "the test methods and evaluation criteria in the evaluation of danger of unkown substances" established by the Maritime Techniques Safety Bureau, Ministry of Transport (December 1985), in order to determine whether or not 1,3 -BAC corresponded to a corrosive substance (class 8) defined in the recommendations of the United Nations concerning the transport of dangerous substances.

As a result, the test substance was judged in accordance with the criteria of the International Maritime Organization (IMO) to corespond to a corrosive substance defined in the recommendations of the United Nations concerning the transport of dangerous substances.

Reference 4

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

This study was not conducted in direct accordance with modern testing methods, and no claim of GLP compliance was made. The test was conducted using a relevant animal species and exposure routeand the study report refers to official test guidelines (although these were not necessarily followed, directly), however the duration of dermal exposure, and the use of abraded skin on some of the exposure sites were inconsistent with modern methods. On this basis the study result was considered reliable with restrictions.

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize, J.H. et al.: J. Pharamcol. Exptl. Therog., 82, 377-390, 1944

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize, J.H.: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", 46 (AOAC) 1959

Qualifier:

equivalent or similar to guideline

Guideline:

other: Federal Register, 43, No. 163, 900-901, 1978

Qualifier:

equivalent or similar to guideline

Guideline:

other: Code of Federal Regulation, title 16, part 1500, 41, 626-627, 1976

Qualifier:

equivalent or similar to guideline

Guideline:

other: Chemicals Inspection & Testing Institute, Japan: OECD Guideline for Testing of Chemicals, 2621-2626, Dai-ichi Hoki Publishing Co, 1981

Principles of method if other than guideline:

The present test, though conducted fundamentally according to Draize's method, includes some changes in the number of animals employed, number of application regions per animal, application time and judgement standard with an objective to comparison of skin irritation of different hardeners.

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Funabashi farm
- Age at study initiation: not specified
- Weight at study initiation:2.2-2.7 kg
- Housing: not specified
- Diet: Solid rabbit diet RCF (Oriental Yeast Co., Ltd.) ad libitum
- Water: ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24+/- 2°C
- Humidity (%): 55 +/- 6%

Type of coverage:

semiocclusive

Preparation of test site:

other: shaved. abraded and intact

Vehicle:

unchanged (no vehicle)

Controls:

other: positive control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.25 ml/region

Duration of treatment / exposure:

24 hours

Observation period:

21 Days

Number of animals:

6, 3 with abraded and 3 with intact skin

Details on study design:

TEST SITE
- Area of exposure: not specified
- % coverage: not specified
- Type of wrap if used: not specified


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours


SCORING SYSTEM:
Erythema Formation, Eschar Formation, Necrosis, and Blooding: None, 0; extremely slight , 1; obvious, 2; medium, 3; severe , 4.

Edema Formation: None, 0; extremely slight , 1; obvious (fringed swelling), 2; medium (swelling about 1mm), 3; severe (heavy swelling over 1mm) , 4.

Remarks on result:

other: see section "Any other information on results incl. tables"

Irritant / corrosive response data:

Immediately after application of 1,3-BAC, erythema appeared and the skin turned brown. Two hours from the beginning, yellow brown or dark brown necrosis was observed in a part of tissue, and 24-hour application caused brown coagulated necrosis in the whole application region. The skin lesion was so strong that no eschar formation was observed even after 21-day application. These findings were common to the intact and abraded skins.

Observation Time		2 hours					24 hours					2 days					3 days					4 days					5 days					6 days					7 days					14 days					21 days
Skin	Rabbit No.	Er	Ed	B	N	Es	Er	Ed	B	N	Es	Er	Ed	B	N	Es	Er	Ed	B	N	Es	Er	Ed	B	N	Es	Er	Ed	B	N	Es	Er	Ed	B	N	Es	Er	Ed	B	N	Es	Er	Ed	B	N	Es	Er	Ed	B	N	Es
Intact	1	4	1	1	1	0	0	0	4	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	1
	2	4	1	1	1	0	0	0	4	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	1
	3	4	1	2	1	0	0	0	4	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	1	0	0	0	4	1	0	0	0	4	2
Abraded	4	4	1	0	1	0	0	0	4	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	1
	5	4	1	2	1	0	0	0	4	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	1
	6	4	1	2	1	0	0	0	4	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	0	0	0	0	4	1

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

Test substance showed severe corrosive lesions immediately upon application.

Executive summary:

A primary skin irritation test was conducted on albino rabbits to compare and determine the strength of primary skin irritation of MXDA-based epoxy resin hardeners. The test results showed corrosive skin lesions induced by 1,3 -BAC.

Reference 5

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Reference 2

Endpoint:

eye irritation: in vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Three studies have been reported, all of which indicate the corrosive nature of the substance.

The key study (SafePharm 1998) was conducted to OECD 404 and under GLP, and showed skin corrosion.

A second study (Niigata Laboratories, 1986) was conducted according to UN methods for skin corrosion and also shows corrosive effects.

A third study (Niigata Laboratories, 1984) was a skin irritation study which also showed irritant / corrosive effects.

The substance is therefore considered to be corrosive to both skin and eyes.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Corrosive effects were reported following 3 minutes' exposure to the skin of one rabbit; observation was carried out up to 1 hour after exposure. On this basis, the classification according to CLP (EC Regulation 1272/2008, employing the GHS system for classification) is corrosive category 1A.

Note that when corrosive category 1A is applied according to CLP, Irreversible effects on the eye Category 1 also applies.