Hexahydro-4,7-methano-1H-indenyl acrylate

Endpoint summary

Description of key information

Dihydrodicyclopentadienyl acrylate is irritant to the skin, and not irritant to the eye. Dihydrodicyclopentadienyl acrylate may be irritating to the respiratory tract.

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: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Principles of method if other than guideline:

The study was conducted following a protocol based on BASF-internal standards.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler / Henning
- Sex: female/male
- Age at study initiation: no data
- Mean body weight at study initiation: female 3.06 kg; male: 3.3 kg
- Diet (ad libitum): Ssniff K, standard diet for rabbits, INTERMAST GmbH, Soest
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
no details given

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin areas of the same animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 1 mL

Duration of treatment / exposure:

1 min, 5 min, 15 min, and 20 h

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: flank and back, 2.5 x 2.5 cm
- Type of wrap if used: the test patch which was wetted with the test substance was applied to the dorsal skin of the rabbits by means of a gummed linen patch that was fastened by an adhesive dressing.


REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lutrol or lutrol:water (1:1) in case of 1, 5, and 15 min application; no washing in case of 20 h application
- Time after start of exposure: after 1, 5, and 15 min


SCORING SYSTEM: Draize Scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(20 h exposure)

Time point:

other: 24-48 hours

Score:

3.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(20 h exposure)

Time point:

other: 24 - 48 hours

Score:

3.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(20 h exposure)

Time point:

other: 24 - 48 hours

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(20 h exposure)

Time point:

other: 24 - 48 hours

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(1, 5, 15 min exposure)

Time point:

other: 24 - 48 hours

Score:

2.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(1, 5, 15 min exposure)

Time point:

other: 24 - 48 hours

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(1, 5, 15 min exposure)

Time point:

other: 24 - 48 hours

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(1, 5, 15 min exposure)

Time point:

other: 24 - 48 hours

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Mean erythema score after 24 and 48 h:

 

Exposure time	Concentration [%]	24 h		48 h		mean
		Animal 1	Animal 2	Animal 1	Animal 2	Animal 1	Animal 2
1 min	100	3**	3**	2*	3**	2.5	3.0
5 min	100	3**	3**	2*	3**	2.5	3.0
15 min	100	3**	3**	2*	3**	2.5	3.0
20 h	100	4*	3**	3*	4**	3.5	3.5

* extending beyond the area of application

** extending far beyond the area of application

 

 

Mean edema score after 24 and 48 h:

 

Exposure time	Concentration [%]	24 h		48 h		mean
		Animal 1	Animal 2	Animal 1	Animal 2	Animal 1	Animal 2
1 min	100	3**	3**	3*	3**	3.0	3.0
5 min	100	3**	3**	3*	3**	3.0	3.0
15 min	100	3**	3**	3*	2**	3.0	2.5
20 h	100	3*	3**	3*	3**	3.0	3.0

* extending beyond the area of application

** extending far beyond the area of application

 

 

 

 

 

Findings at test termination:

 

Exposure time	Concentration [%]	Skin findings
		Animal 1	Animal 2
1 min	100	desquamation	desquamation
5 min	100	desquamation	desquamation
15 min	100	desquamation	desquamation
20 h	100	desquamation	desquamation*

* extending beyond the area of application

 

Interpretation of results:

irritating

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

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: Comparable to guideline study, acceptable for assessment.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted 1981)

Deviations:

yes

Remarks:

Only 0.05 mL applied (instead of 0.1 mL), observation period: only 8 days (instead of 21 days)

Principles of method if other than guideline:

The study was conducted following a protocol based on BASF-internal standards.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.99 kg (male) and 2.82 kg (female)


ENVIRONMENTAL CONDITIONS
no details given

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

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

Duration of treatment / exposure:

once

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

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


SCORING SYSTEM: Draize Scoring System


TOOL USED TO ASSESS SCORE: none

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 - 48 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 5 days

Remarks on result:

other: (animals 1 and 2 had identical scores)

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 48 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 - 48 hours

Score:

0

Max. score:

2

Reversibility:

other: no effects

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 - 48 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Mean scores after 24 and 48 h*:

 

Scores	24 h		48 h		mean
	Animal 1	Animal 2	Animal 1	Animal 2	Animal 1	Animal 2
Conjunctivae	1	1	1	1	1	1
Cornea	0	0	0	0	0	0
Chemosis	0	0	0	0	0	0
Iritis	0	0	0	0	0	0
Discharge	0	0	0	0	0	0

*72 hrs-scores were missing in the raw data.

 

 

 

Findings at test termination:

 

Scores	8 d
	Animal 1	Animal 2
Conjunctivae	0	0
Cornea	0	0
Chemosis	0	0
Iritis	0	0
Discharge	0	0

 

 

Interpretation of results:

not irritating

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin irritation:

In the key study (BASF AG, 1980) one mL of undiluted dihydrodicyclopentadienyl acrylate was applied to the intact dorsal skin of New Zealand white rabbits under occlusive conditions. The test material was applied to 2 rabbits for 1, 5, 15 minutes, and for 20 hours. Independent of exposure time, erythema (grade 3-4) as well as edema (grade 3) was present 24 h after beginning of exposure period. Means for erythema (24-48 h) and edema (24-48 h) were 3.5 (both animals) and 3.0 (both animals) after exposure for 20 h, respectively. Slightly lower mean values for erythema (2.5 and 3.0) and edema (3.0 and 2.5) were observed after exposure for 15 min. Scaling was observed at the end of the observation period on both animals independent of exposure time.

 

In a supporting study (BASF AG, 1966) similar to the key study erythema (grade 2-3) were present 24 h after beginning of exposure period, independent of exposure time. No edema was observed, independent of exposure time and observation date. Means for erythema (24-72 h) were 2.0 and 2.7 after exposure for 20 h and 2.7 and 3.0 after exposure for 15 min, respectively. Scaling was observed at the end of the observation period on both animals after exposure time of 15 min and 20 h, respectively.

 

In another study (BASF AG, 1964) erythema (grade 2-3) and edema (grade 2-3) were present 24 h after beginning of exposure period, depending on time of exposure. Means for erythema (24-72 h) were 3.3 and 3.3 after exposure for 20 h and 3.0 and 2.3 after exposure for 15 min, respectively. Means for edema (24-72 h) were 2.7 and 3.0 after exposure for 20 h and 1.3 and 0.7 after exposure for 15 min, respectively. Scaling was observed at the end of the observation period on both animals independent of exposure time.

 

Thus, dicyclopentadienyl acrylate  was assessed to be irritating to the skin, proposed for classification and labeling in category 2 according to REGULATION (EC) No 1272/2008 and Irritating to the skin (R38) according to Annex VI of Directive 67/548/EEC.

 

 

Eye irritation:

Undiluted dicyclopentadienyl acrylate (0.05 mL) was instilled into the eye of 1 female and 1 male New Zealand White rabbit int the key

study (BASF AG, 1980). The study was conducted similar to OECD TG No. 405, with the restriction that only 0.05 instead of 0.1 mL dicyclopentadienyl acrylate was applied, and the observation period was 8 d instead of 14 days. The eyes were examined 1h, 24 h, 48 h and 8 d after instillation of dicyclopentadienyl acrylate. The eyes were not washed out following instillation. Slight conjunctival redness (grade 1) was noted in all animals after 24 and 48 h, and disappeared after the end of observation (8 d). No other effects on the eye were observed.

 

In two supporting studies (BASF AG, 1966 and BASF AG, 1964) 2 animals each were treated with 0.05 mL dicyclopentadienyl acrylate. Test substance was not washed out, and observations were performed 1 h, 24 h, 48 h and 8 d after beginning of exposure. Slight or no conjunctival redness was observed after 24 h (grade 0-1), whereas no conjunctival redness was observed after 48 h. No other effects were observed.

 

Thus, dicyclopentadienyl acrylate is not irritant to the eye, deducing no classification and labeling according to REGULATION (EC) No 1272/2008 and according to Annex VI of Directive 67/548/EEC.

 

Respiratory irritation:

In two studies regarding the acute toxicity of dicyclopentadienyl acrylate by inhalation clinical symptoms were found indicating respiratory irritation. These two inhalation hazard tests (BASF AG, 1966 and BASF AG, 1964) were performed with a nominal concentration of up to 1.64 mg/L air for 8 h. No mortality occured. The following clinical signs were observed which indicate respiratory irritation: slight mucosal irritation and nasal secretion.

 

Taking into consideration the skin irritating properties of the substance, and the findings in the acute inhalation studies, dicyclopentadienyl acrylate is likely to be a respiratory irritant.

Justification for selection of skin irritation / corrosion endpoint:
The key study was selected.

Justification for selection of eye irritation endpoint:
The key study was selected

Effects on skin irritation/corrosion: irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data are reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification and labeling with Xi, R38 is proposed.

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008 (last amended by EC/286/2008 (2011-03-10)):

Classification as irritant to the skin (Category 2).

No classification for eye irritation is required.

Nevertheless, for the group of substances (monoalkyl or monoaryl or monoalkyaryl esters of acrylic acid) an entry in Table 3.1 and 3.2 of Annex VI of Regulation (EC) No 1272/2008 exists which has to be adopted for the test substance. Thus, the substance is classified as Xi (irritant), R36/37/38 (irritating to eyes, respiratory system and skin) according to Directive 67/548/EEC (DSD) and as skin irrit. cat. 2 (H315, causes skin irritation), eye irrit. cat. 2 (H319, causes serious eye irritation) and as STOT SE cat. 3 (May cause respiratory irritation) according to Regulation (EC) No 1272/2008 (GHS/CLP).