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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

Category Approach for three different 3-aminocrotonic acid esters

Testsystem

-         

(CAS-No. 14205-39-1)

-         Isopropylester

(CAS-No. 14205-46-0)

-         Isobutylester

(CAS-No. 52937-90-3)

Akut oral

Classification with R 22/ Acute Tox 4

LD50:1760 mg/kg

Results: 1300 mg without findings,

≥1500 narcosis, cyanosis, etc.;

irritation in the stomach mucosa

(Bayer internal report: Löser, 1983-06-30, T2015646)

No classification

LD50: > 2000 mg/kg

Results: limit dose study; piloerection and diuresis up to 48 h after dosing

(Bayer internal report: Bomhard, 1989-03-01, No. 17779)

Classification with R 22 / Acute Tox 4

LD50:1400 mg/kg

Results: 1000 mg without findings,

≥1300 mortality; narcosis, cyanosis, etc.

irritation in the stomach mucosa

(Bayer internal report: Ramm, 1985-11-12, No. T0020251)

Akut inh.

LC50 > 23 mg/m³ (dust; maximal technically feasible concentration)

(Bayer internal report: Pauluhn, 1983-04-27, No. 11752)

>6064 mg/m³ (aerosol)

(Bayer internal report: Pauluhn, 1989-06-20, No. 18104)

No data

Skin irritation

No classification

Bayer report: Slight skin irritation (erythema grade 2, 24h; grade 1, 48h)

Lonza report: No skin irritation

(Bayer internal report: Schmidt, 1983-08-04, T5045748)

No classification

Slight skin irritation (erythema 0.3-1.0)

(Bayer internal report: Märtins, 1989-03-20, No. 17843)

No classification

No data available

Slight irritation expeced via category approach

 

Eye irritation

Classification with R 41/ Eye Damage 1

Bayer report: Slight irritation (mean: cornea 0.3-0.7; erythema 1.3-2.0; chemosis 1.3-2.3)

Lonza report: 1 animal with cornea grade 2 not reversible; animal 2 and 3: slight

(Bayer internal report: Schmidt, 1983-08-03, T6015767)

(Lonza report: Donald, 2000-03-23, No. 3202)

Classification with R 36 / Eye Damage 2

Cornea grade 1-2, erythema grade 1-2, reversible

(Bayer internal report: Märtins, 1989-03-20, No. 17843)

Classification with R 36 / Eye Damage 2

No data available

Eye irritation expeced via category aproach

 

Skin sensi

Classification with R 43 / Skin sens 1 B

Bayer report: M&K neg (paraffin; 5%, 12%, 1%; 1.challenge 3/10, 2. 1/10)

Lonza report: M&K positive (maize oil, induction max. practicable conc.; challenge: max non-irritant conc. ; 4%, 60%, 60%; 10/10);

QSAR toolbox predicts moderate skin sensitization potential (via Michael addition)

(Bayer internal report: Stropp, 1997-08-07, No. 26525)

(Lonza report: Donald, 2000-03-23, No. 3204)

Classification with R 43/ Skin sens 1 B

No animal data available

QSAR toolbox predicts moderate skin sensitization potential (via Michael addition)

Moderate skin sensitizing potential expected via category approach and QSAR

 

Classification with R 43 / Skin sens 1 B

No animal data available

QSAR toolbox predicts moderate skin sensitization potential (via Michael addition)

Moderate skin sensitizing potential expected via category approach and QSAR

 

Ames Test

(4 Salmonella strains)

No classification

Negativ

(Bayer internal report: Herbold, 1986-01-07, No. 14189)

No classification

Negativ

(Bayer internal report: Herbold, 1990-08-08, No. 19390 plus Amendment of 1994)

No classification

Negativ

(Bayer internal report: Herbold, 1986-04-01, No. 14493)

In vivo mouse bone marrow MNT

No data

Negativ

(Bayer internal report: Herbold, 1990-05-29, No. 19096 plus Amendment of 1994)

No data

 

Justification for classification or non-classification

Based on a category approach with three different 3 -aminocrotonic acid esters, 3 -aminocrotonic acid butyl ester should be classified as skin sensitizer with Xi, R43 according to Directive 67/548/EEC. According to Regulation (EC) No. 1272/2008 (CLP) and the amending Regulation (EC) No. 286/2011, the substance should be classified as skin sensitizer Category 1B (H317).

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